| Model Number |
ESS305 |
| Medical Device Problem Codes |
Break (1069); Improper or Incorrect Procedure or Method (2017)
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| Health Effect - Clinical Codes |
Abdominal Pain (1685); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Abdominal Distention (2601); Menorrhagia (4508); Pelvic Pain (4865)
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| Date of Event |
10/01/2018
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Type of Reportable Event
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Serious Injury
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Event or Problem Description
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Bayer case number: (b)(4) pelvic pain radiating to her lower back [pelvic pain female] , fragment of the essure [device breakage] , menorrhagia [menorrhagia] , uncontrolled angina.[unstable angina] , endometrial hypotrophy [endometrial atrophy] , abdominal bloating [abdominal bloating], back pain [back pain] , flu-like symptoms [flu-like symptoms] , severe fatigue [fatigue extreme] , severe lumbago [lumbago] , inability to move her legs [lower extremity dysfunction] , sick leave [sick leave] , abdomen remained swollen [swollen abdomen] , possible pre-menopause [premenopause] , generalised pain [generalised aching] , sensation of being ¿run over by a steamroller [feeling unwell] , abdominal pain [abdominal pain] , left-sided lumbocruralgia [lumbocrural pain] , pain in the sacroiliac joints [pain sacroiliac] , leg pain [leg pain] , dizziness [dizziness] , nickel allergy [nickel allergy] , worsening inflammation [inflammation], psoas haematoma [hematoma muscle] , pain persisted in the right iliac fossa [iliac fossa pain] , stiff legs [limbs stiffness] , heavy legs [heaviness in limbs] , weight loss 10 kg [weight loss] , central sensitisation syndrome [central sensitisation] , dysaesthesia [dysaesthesia] , persistent muscular pain [muscular pain], ocular pain [ocular pain] , metal poisoning [metal poisoning] , led to episodes of depression [depression] , florid adenomyosis [adenomyosis] , lesions of the right crural and femoral nerve root [peripheral nerve lesion] , headaches [headache] , tinnitus [tinnitus] , visual disturbances [visual disturbances], insomnia [insomnia] , eczema [eczema] , chest pain [chest pain] , coronary spasm [coronary spasm] , flu-like symptom [flu-like symptoms] , underwent essure insertion and endometrial thermal ablation using novasure [medical device monitoring error].Case narrative: this spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain radiating to her lower back"), device breakage ("fragment of the essure"), heavy menstrual bleeding ("menorrhagia") and angina unstable ("uncontrolled angina.") in a 50-year-old female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: medical device monitoring error ("underwent essure insertion and endometrial thermal ablation using novasure").The patient had a medical history of painful intercourse, fatigue and prolonged heavy periods in 2014, appendectomy in 2004, multidrug resistant bacterial infection in 2003 and endometrial thickening and nickel allergy.Previously administered products included: luteran and mirena.On (b)(6) 2016, the patient had essure inserted.On (b)(6) 2016, 75 days after essure insertion, she experienced lumbago ("severe lumbago").In 2016 she experienced abdominal bloating ("abdominal bloating"), back pain ("back pain"), a first episode of influenza like illness ("flu-like symptoms") and fatigue ("severe fatigue").In (b)(6) 2018 she experienced device breakage (seriousness criterion intervention required).In (b)(6) 2018 she experienced central pain syndrome ("central sensitisation syndrome").On unknown date she experienced pelvic pain (seriousness criteria hospitalisation and intervention required), heavy menstrual bleeding (seriousness criterion intervention required), angina unstable (seriousness criterion hospitalisation), endometrial atrophy ("endometrial hypotrophy"), musculoskeletal disorder ("inability to move her legs"), sick leave ("sick leave"), swollen abdomen ("abdomen remained swollen"), menopause ("possible pre-menopause"), pain ("generalised pain"), malaise ("sensation of being ¿run over by a steamroller"), abdominal pain ("abdominal pain"), sciatica ("left-sided lumbocruralgia"), sacral pain ("pain in the sacroiliac joints"), pain in extremity ("leg pain"), dizziness ("dizziness"), allergy to metals ("nickel allergy"), inflammation ("worsening inflammation"), haematoma muscle ("psoas haematoma"), abdominal pain lower ("pain persisted in the right iliac fossa"), musculoskeletal stiffness ("stiff legs"), limb discomfort ("heavy legs"), dysaesthesia ("dysaesthesia"), myalgia ("persistent muscular pain"), eye pain ("ocular pain"), metal poisoning ("metal poisoning"), depression (" led to episodes of depression"), adenomyosis (" florid adenomyosis"), peripheral nerve lesion (" lesions of the right crural and femoral nerve root"), headache ("headaches"), tinnitus ("tinnitus"), visual impairment ("visual disturbances"), insomnia ("insomnia"), eczema ("eczema"), chest pain ("chest pain"), arteriospasm coronary ("coronary spasm") and a second episode of influenza like illness ("flu-like symptom") and was found to have weight decreased ("weight loss 10 kg").The patient was hospitalised from (b)(6) 2017 for an unknown duration.The patient was treated with isoptin (verapamil), natispray (glyceryl trinitrate) and ketamine (ketamine hydrochloride) as well as surgery (on (b)(6) 2017 bilateral laparoscopic salpingectomy, on (b)(6) 2017 hysterectomy and abaltion).At the time of the report, the abdominal pain lower, musculoskeletal stiffness, limb discomfort and weight decreased had not resolved.The outcomes for pelvic pain, device breakage, heavy menstrual bleeding, abdominal bloating, back pain, fatigue, lumbago, musculoskeletal disorder, sick leave, swollen abdomen, menopause, pain, malaise, abdominal pain, sciatica, sacral pain, pain in extremity, dizziness, allergy to metals, inflammation, haematoma muscle, central pain syndrome, dysaesthesia, myalgia, eye pain, metal poisoning, depression, adenomyosis, peripheral nerve lesion, headache, tinnitus, visual impairment, insomnia, eczema, chest pain, arteriospasm coronary and the last episode of influenza like illness were unknown.The reporter considered abdominal bloating, swollen abdomen, abdominal pain, abdominal pain lower, adenomyosis, allergy to metals, angina unstable, arteriospasm coronary, lumbago, back pain, central pain syndrome, chest pain, depression, device breakage, dizziness, dysaesthesia, eczema, endometrial atrophy, eye pain, fatigue, haematoma muscle, headache, heavy menstrual bleeding, inflammation, the first episode of influenza like illness, the second episode of influenza like illness, insomnia, limb discomfort, malaise, menopause, metal poisoning, musculoskeletal disorder, musculoskeletal stiffness, myalgia, pain, pain in extremity, pelvic pain, peripheral nerve lesion, sacral pain, sciatica, sick leave, tinnitus, visual impairment and weight decreased to be related to essure administration.The reporter commented: she therefore underwent a bilateral laparoscopic salpingectomy on (b)(6) 2017.She underwent surgery on (b)(6) 2017 for a laparoscopically assisted total hysterectomy via the vaginal route, as she was still experiencing pelvic pain following the salpingectomy and removal of the implants.The operation revealed nothing abnormal: she was discharged six days later.Following the hysterectomy, her recovery was difficult, marked by a feeling of not being listened to and a lack of information regarding the effects of nickel and the implants.It was difficult to secure a post-operative consultation.Diagnostic results (normal ranges are provided in parenthesis if available): [abdominal x-ray] on (b)(6) 2017: nothing abnormal: no essure implants were visible in the pelvic region [computerised tomogram] on (b)(6) 2017: nothing abnormal and was unremarkable [computerised tomogram pelvis] on (b)(6) 2017: nothing abnormal was found [histology] on (b)(6) 2016: probable endometrial hypotrophy [magnetic resonance imaging] on (b)(6) 2017: the results were normal: no mri findings suggestive of sacroiliitis.No disc herniation or visible disc-root conflict in the lumbar spine.; on (b)(6) 2017: nothing abnormal was found.Case comments: based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.In case a sample is received the investigation might lead to destruction of the sample if required to perform a proper analysis.
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Additional Manufacturer Narrative
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Bayer case number: (b)(4).Pelvic pain radiating to her lower back [pelvic pain female].Fragment of the essure [device breakage].Menorrhagia [menorrhagia].Uncontrolled angina.[unstable angina].Endometrial hypotrophy [endometrial atrophy].Abdominal bloating [abdominal bloating].Back pain [back pain].Flu-like symptoms [flu-like symptoms].Severe fatigue [fatigue extreme].Severe lumbago [lumbago].Inability to move her legs [lower extremity dysfunction].Sick leave [sick leave].Abdomen remained swollen [swollen abdomen].Possible pre-menopause [premenopause].Generalised pain [generalised aching].Sensation of being ¿run over by a steamroller [feeling unwell].Abdominal pain [abdominal pain].Left-sided lumbocruralgia [lumbocrural pain].Pain in the sacroiliac joints [pain sacroiliac].Leg pain [leg pain].Dizziness [dizziness].Nickel allergy [nickel allergy].Worsening inflammation [inflammation].Psoas haematoma [hematoma muscle].Pain persisted in the right iliac fossa [iliac fossa pain].Stiff legs [limbs stiffness].Heavy legs [heaviness in limbs].Weight loss 10 kg [weight loss].Central sensitisation syndrome [central sensitisation].Dysaesthesia [dysaesthesia].Persistent muscular pain [muscular pain].Ocular pain [ocular pain].Metal poisoning [metal poisoning].Led to episodes of depression [depression].Florid adenomyosis [adenomyosis].Lesions of the right crural and femoral nerve root [peripheral nerve lesion].Headaches [headache].Tinnitus [tinnitus].Visual disturbances [visual disturbances].Insomnia [insomnia].Eczema [eczema].Chest pain [chest pain].Coronary spasm [coronary spasm].Flu-like symptom [flu-like symptoms].Underwent essure insertion and endometrial thermal ablation using novasure [medical device monitoring error].Case narrative: this spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain radiating to her lower back"), device breakage ("fragment of the essure"), heavy menstrual bleeding ("menorrhagia") and angina unstable ("uncontrolled angina.") in a 50 year-old female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: medical device monitoring error ("underwent essure insertion and endometrial thermal ablation using novasure").The patient had a medical history of painful intercourse, fatigue and prolonged heavy periods in 2014, appendectomy in 2004, multidrug resistant bacterial infection in 2003 and endometrial thickening and nickel allergy.Previously administered products included: luteran and mirena.On (b)(6) 2016, the patient had essure inserted.On (b)(6) 2016, 75 days after essure insertion, she experienced lumbago ("severe lumbago").In 2016 she experienced abdominal bloating ("abdominal bloating"), back pain ("back pain"), a first episode of influenza like illness ("flu-like symptoms") and fatigue ("severe fatigue").In (b)(6) 2018 she experienced device breakage (seriousness criterion intervention required).In (b)(6) 2018 she experienced central pain syndrome ("central sensitisation syndrome").On unknown date she experienced pelvic pain (seriousness criteria hospitalisation and intervention required), heavy menstrual bleeding (seriousness criterion intervention required), angina unstable (seriousness criterion hospitalisation), endometrial atrophy ("endometrial hypotrophy"), musculoskeletal disorder ("inability to move her legs"), sick leave ("sick leave"), swollen abdomen ("abdomen remained swollen"), menopause ("possible pre-menopause"), pain ("generalised pain"), malaise ("sensation of being ¿run over by a steamroller"), abdominal pain ("abdominal pain"), sciatica ("left-sided lumbocruralgia"), sacral pain ("pain in the sacroiliac joints"), pain in extremity ("leg pain"), dizziness ("dizziness"), allergy to metals ("nickel allergy"), inflammation ("worsening inflammation"), haematoma muscle ("psoas haematoma"), abdominal pain lower ("pain persisted in the right iliac fossa"), musculoskeletal stiffness ("stiff legs"), limb discomfort ("heavy legs"), dysaesthesia ("dysaesthesia"), myalgia ("persistent muscular pain"), eye pain ("ocular pain"), metal poisoning ("metal poisoning"), depression ("led to episodes of depression"), adenomyosis ("florid adenomyosis"), peripheral nerve lesion ("lesions of the right crural and femoral nerve root"), headache ("headaches"), tinnitus ("tinnitus"), visual impairment ("visual disturbances"), insomnia ("insomnia"), eczema ("eczema"), chest pain ("chest pain"), arteriospasm coronary ("coronary spasm") and a second episode of influenza like illness ("flu-like symptom") and was found to have weight decreased ("weight loss 10 kg").The patient was hospitalised from (b)(6) 2017 for an unknown duration.The patient was treated with isoptin (verapamil), natispray (glyceryl trinitrate) and ketamine (ketamine hydrochloride) as well as surgery (on (b)(6) 2017 bilateral laparoscopic salpingectomy, on (b)(6) 2017 hysterectomy and abaltion).At the time of the report, the abdominal pain lower, musculoskeletal stiffness, limb discomfort and weight decreased had not resolved.The outcomes for pelvic pain, device breakage, heavy menstrual bleeding, abdominal bloating, back pain, fatigue, lumbago, musculoskeletal disorder, sick leave, swollen abdomen, menopause, pain, malaise, abdominal pain, sciatica, sacral pain, pain in extremity, dizziness, allergy to metals, inflammation, haematoma muscle, central pain syndrome, dysaesthesia, myalgia, eye pain, metal poisoning, depression, adenomyosis, peripheral nerve lesion, headache, tinnitus, visual impairment, insomnia, eczema, chest pain, arteriospasm coronary and the last episode of influenza like illness were unknown.The reporter considered abdominal bloating, swollen abdomen, abdominal pain, abdominal pain lower, adenomyosis, allergy to metals, angina unstable, arteriospasm coronary, lumbago, back pain, central pain syndrome, chest pain, depression, device breakage, dizziness, dysaesthesia, eczema, endometrial atrophy, eye pain, fatigue, haematoma muscle, headache, heavy menstrual bleeding, inflammation, the first episode of influenza like illness, the second episode of influenza like illness, insomnia, limb discomfort, malaise, menopause, metal poisoning, musculoskeletal disorder, musculoskeletal stiffness, myalgia, pain, pain in extremity, pelvic pain, peripheral nerve lesion, sacral pain, sciatica, sick leave, tinnitus, visual impairment and weight decreased to be related to essure administration.The reporter commented: she therefore underwent a bilateral laparoscopic salpingectomy on (b)(6) 2017.She underwent surgery on (b)(6) 2017 for a laparoscopically assisted total hysterectomy via the vaginal route, as she was still experiencing pelvic pain following the salpingectomy and removal of the implants.The operation revealed nothing abnormal: she was discharged six days later.Following the hysterectomy, her recovery was difficult, marked by a feeling of not being listened to and a lack of information regarding the effects of nickel and the implants.It was difficult to secure a post-operative consultation.Diagnostic results (normal ranges are provided in parenthesis if available): [abdominal x-ray] on (b)(6) 2017: nothing.Abnormal: no essure implants were visible in the pelvic region.[computerised tomogram] on (b)(6) 2017: nothing abnormal and was unremarkable.[computerised tomogram pelvis] on (b)(6) 2017: nothing abnormal was found.[histology] on (b)(6) 2016: probable endometrial hypotrophy.[magnetic resonance imaging] on (b)(6) 2017: the results were normal: no mri findings suggestive of sacroiliitis.No disc.Herniation or visible disc-root conflict in the lumbar spine.; on (b)(6) 2017: nothing abnormal was found.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly; no signal was observed with regard to the reason for the reported complaint.The risk management file was reviewed, and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 10-apr-2026: upon receipt of new follow up argus cases (b)(4) & (b)(4) are found to be duplicate of each other therefore argus case (b)(4) needs to nullify from argus database.All events, references, and relevant information have been transferred to retention case.Case comments: based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.In case a sample is received the investigation might lead to destruction of the sample if required to perform a proper analysis.
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Additional Manufacturer Narrative
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Bayer case number: (b)(4).Pelvic pain radiating to her lower back [pelvic pain female], fragment of the essure [device breakage], menorrhagia [menorrhagia], uncontrolled angina.[unstable angina], endometrial hypotrophy [endometrial atrophy], abdominal bloating [abdominal bloating], back pain [back pain], flu-like symptoms [flu-like symptoms], severe fatigue [fatigue extreme], severe lumbago [lumbago], inability to move her legs [lower extremity dysfunction], sick leave [sick leave], abdomen remained swollen [swollen abdomen], possible pre-menopause [premenopause], generalised pain [generalised aching], sensation of being ¿run over by a steamroller [feeling unwell], abdominal pain [abdominal pain], left-sided lumbocruralgia [lumbocrural pain], pain in the sacroiliac joints [pain sacroiliac], leg pain [leg pain], dizziness [dizziness], nickel allergy [nickel allergy], worsening inflammation [inflammation], psoas haematoma [hematoma muscle], pain persisted in the right iliac fossa [iliac fossa pain], stiff legs [limbs stiffness], heavy legs [heaviness in limbs], weight loss 10 kg [weight loss], central sensitisation syndrome [central sensitisation], dysaesthesia [dysaesthesia], persistent muscular pain [muscular pain], ocular pain [ocular pain], metal poisoning [metal poisoning], led to episodes of depression [depression], florid adenomyosis [adenomyosis], lesions of the right crural and femoral nerve root [peripheral nerve lesion], headaches [headache], tinnitus [tinnitus], visual disturbances [visual disturbances], insomnia [insomnia], eczema [eczema], chest pain [chest pain], coronary spasm [coronary spasm], flu-like symptom [flu-like symptoms], underwent essure insertion and endometrial thermal ablation using novasure [medical device monitoring error].Case narrative: this spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain radiating to her lower back"), device breakage ("fragment of the essure"), heavy menstrual bleeding ("menorrhagia") and angina unstable ("uncontrolled angina.") in a 50 year-old female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: medical device monitoring error ("underwent essure insertion and endometrial thermal ablation using novasure").The patient had a medical history of painful intercourse, fatigue and prolonged heavy periods in 2014, appendectomy in 2004, multidrug resistant bacterial infection in 2003 and endometrial thickening and nickel allergy.Previously administered products included: luteran and mirena.On (b)(6) 2016, the patient had essure inserted.On (b)(6) 2016, 75 days after essure insertion, she experienced lumbago ("severe lumbago").In 2016 she experienced abdominal bloating ("abdominal bloating"), back pain ("back pain"), a first episode of influenza like illness ("flu-like symptoms") and fatigue ("severe fatigue").In (b)(6) 2018 she experienced device breakage (seriousness criterion intervention required).In (b)(6) 2018 she experienced central pain syndrome ("central sensitisation syndrome").On unknown date she experienced pelvic pain (seriousness criteria hospitalisation and intervention required), heavy menstrual bleeding (seriousness criterion intervention required), angina unstable (seriousness criterion hospitalisation), endometrial atrophy ("endometrial hypotrophy"), musculoskeletal disorder ("inability to move her legs"), sick leave ("sick leave"), swollen abdomen ("abdomen remained swollen"), menopause ("possible pre-menopause"), pain ("generalised pain"), malaise ("sensation of being ¿run over by a steamroller"), abdominal pain ("abdominal pain"), sciatica ("left-sided lumbocruralgia"), sacral pain ("pain in the sacroiliac joints"), pain in extremity ("leg pain"), dizziness ("dizziness"), allergy to metals ("nickel allergy"), inflammation ("worsening inflammation"), haematoma muscle ("psoas haematoma"), abdominal pain lower ("pain persisted in the right iliac fossa"), musculoskeletal stiffness ("stiff legs"), limb discomfort ("heavy legs"), dysaesthesia ("dysaesthesia"), myalgia ("persistent muscular pain"), eye pain ("ocular pain"), metal poisoning ("metal poisoning"), depression (" led to episodes of depression"), adenomyosis (" florid adenomyosis"), peripheral nerve lesion (" lesions of the right crural and femoral nerve root"), headache ("headaches"), tinnitus ("tinnitus"), visual impairment ("visual disturbances"), insomnia ("insomnia"), eczema ("eczema"), chest pain ("chest pain"), arteriospasm coronary ("coronary spasm") and a second episode of influenza like illness ("flu-like symptom") and was found to have weight decreased ("weight loss 10 kg").The patient was hospitalised from (b)(6) 2017 for an unknown duration.The patient was treated with isoptin (verapamil), natispray (glyceryl trinitrate) and ketamine (ketamine hydrochloride) as well as surgery (on (b)(6) 2017 bilateral laparoscopic salpingectomy, on (b)(6) 2017 hysterectomy and abaltion).At the time of the report, the abdominal pain lower, musculoskeletal stiffness, limb discomfort and weight decreased had not resolved.The outcomes for pelvic pain, device breakage, heavy menstrual bleeding, abdominal bloating, back pain, fatigue, lumbago, musculoskeletal disorder, sick leave, swollen abdomen, menopause, pain, malaise, abdominal pain, sciatica, sacral pain, pain in extremity, dizziness, allergy to metals, inflammation, haematoma muscle, central pain syndrome, dysaesthesia, myalgia, eye pain, metal poisoning, depression, adenomyosis, peripheral nerve lesion, headache, tinnitus, visual impairment, insomnia, eczema, chest pain, arteriospasm coronary and the last episode of influenza like illness were unknown.The reporter considered abdominal bloating, swollen abdomen, abdominal pain, abdominal pain lower, adenomyosis, allergy to metals, angina unstable, arteriospasm coronary, lumbago, back pain, central pain syndrome, chest pain, depression, device breakage, dizziness, dysaesthesia, eczema, endometrial atrophy, eye pain, fatigue, haematoma muscle, headache, heavy menstrual bleeding, inflammation, the first episode of influenza like illness, the second episode of influenza like illness, insomnia, limb discomfort, malaise, menopause, metal poisoning, musculoskeletal disorder, musculoskeletal stiffness, myalgia, pain, pain in extremity, pelvic pain, peripheral nerve lesion, sacral pain, sciatica, sick leave, tinnitus, visual impairment and weight decreased to be related to essure administration.The reporter commented: she therefore underwent a bilateral laparoscopic salpingectomy on (b)(6) 2017.She underwent surgery on (b)(6) 2017 for a laparoscopically assisted total hysterectomy via the vaginal route, as she was still experiencing pelvic pain following the salpingectomy and removal of the implants.The operation revealed nothing abnormal: she was discharged six days later.Following the hysterectomy, her recovery was difficult, marked by a feeling of not being listened to and a lack of information regarding the effects of nickel and the implants.It was difficult to secure a post-operative consultation.Diagnostic results (normal ranges are provided in parenthesis if available): [abdominal x-ray] on (b)(6) 2017: nothing abnormal: no essure implants were visible in the pelvic region.[computerised tomogram] on (b)(6) 2017: nothing abnormal and was unremarkable.[computerised tomogram pelvis] on (b)(6) 2017: nothing abnormal was found.[histology] on (b)(6) 2016: probable endometrial hypotrophy.[magnetic resonance imaging] on (b)(6) 2017: the results were normal: no mri findings suggestive of sacroiliitis.No disc herniation or visible disc-root conflict in the lumbar spine.; on (b)(6) 2017: nothing abnormal was found.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly; no signal was observed with regard to the reason for the reported complaint.The risk management file was reviewed, and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 02-apr-2026: quality safety evaluation of product technical complaint.Case comments: based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.In case a sample is received the investigation might lead to destruction of the sample if required to perform a proper analysis.
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