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| Catalog Number LTXXX |
| Device Problems
Insufficient Information (3190); Patient Device Interaction Problem (4001)
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| Patient Problems
Dysphagia/ Odynophagia (1815); Dyspnea (1816); Pain (1994); Choking (2464)
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| Event Date 01/01/2015 |
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain additional information.To date, no additional information has been received.If the device or further details are received at a later date, a supplemental medwatch will be sent: email sent to consumer/friend of the patient to provide the patient with our complaint inbox email address and complaint reference number.Email was sent and emphasized that the patient should only contact us if she wishes to do so, it is completely voluntary and there is no requirement for this patient to contact our company.Email also emphasized that the consumer/friend should not reply back to provide the patient's contact information due to patient privacy laws.Additional information received (neck x-ray attached to medwatch file): a neck x-ray was provided by consumer/friend and was attached to file.The x-ray review is in progress and not yet completed.Upon completion of review, a supplemental medwatch will be sent.
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Event Description
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It was reported by consumer that "my friend had 23 or 24 clips put in her neck, without her knowledge, during a thyroidectomy.She suffered for 6 years with poking, sharp pain when swallowing.She recently had them removed and feels much better, no more poking, sharpness when swallowing.¿.
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Manufacturer Narrative
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(b)(4).Date sent: 6/23/2021.H2: additional information received: medical records attached to medwatch report: pathology report (b)(6) 2021.Photo of removed clips (b)(6) 2021.
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Manufacturer Narrative
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(b)(4).Date sent: 5/19/2021.D4: batch#: unk.B3: date of event is 2015.Event day and event month were not reported.H2: additional information received: additional information and photos received from friend and patient: "in 2015, i underwent a thyroidectomy.After the surgery i told the doctor that i felt a poking feeling in my neck.The doctor said that it should go away after a few weeks.Months later, i still felt chronic pain every time i swallowed food or drank water and frequent coughing.I went to 6 ent doctors and two endocrinologists in the last 6 years.I was told to take several pain medications to treat an acid reflex that might have been causing the pain.Two different ent doctors placed me on acid reflex medication.I also had an endoscopy in 2019.Regardless, i followed each of their instructions to no avail.None of the medications helped alleviate my pain.On (b)(6) 2019, i was referred by a friend to see a chiropractor to help with my back pain.In the office, i told the chiropractor my story about the pain when i eat and he told me that he needs to take x-rays before any treatment.From the x-rays he took, he found 27 clips in my throat and he asked me if i knew about this.I was surprised since no one previously told me about this.My chiropractor referred me back to my original surgeon to look for answers.On (b)(6) 2019, i set up an appointment with the surgeon and brought my x-rays.He was very defensive to all my questions and i asked why he never disclosed to me why he left so many clips.He told me that "he was not obligated to tell his patience his medical practice." i told him, yes you are obligated because it is my body and my life and you left staples in my neck and you shouldn't be putting ci".He told me that he did not recommend to let anybody do any type of surgery to remove the clips because the solution would be worse than what i'm dealing with now because the nerves in my neck could be damaged.And the only solution he told me to do is for me to go to a pain management clinic to deal with my pain and told me there is nothing else he can do.That day i left his office crying and i felt very miserable.While working or any place i always felt constant pain.On (b)(6) 2020, i went to usf to see a specialist (ent) and the doctors that i set up the appointment did not bother to hear me what i need to said or even took the time to see my x-rays.The appointment was less than five minutes and told me that he is not the doctors that can remove the clips and he left the office.In 2020, i decided to join an online group who had the same issues that i did.On (b)(6) 2021, one of the members told me to visit a surgeon that was in my area.After sending an email, i received a call the same day from the surgeon and booked an appointment to remove the clips.Only 10 clips could be removed.I still have more than 11 clips inside and no idea if this could cause issue in the future.I still need to wait for the recovery after the surgery but sometimes i still cough.Photos were also received for review by analysis team and ethicon medical safety.During the visual analysis, the following was observed: one photo shows an x-ray and there appears to see some clips in the image.Additional photos were added and were reviewed by ethicon medical safety officer and review is as follows: i reviewed four photographs associated with this complaint.There were two lateral neck x-rays of the patient referred to in this complaint.The first was dated on (b)(6) 2019, which relevant to the complaint showed approximately sixteen surgical clips of various sizes in the anterior part of the neck.The second neck x-ray was dated on (b)(6) 2021, which relevant to the complaint showed approximately eleven surgical clips of various sizes in the anterior part of the neck.There were less clips visible on the second x ray and some of the previously placed clips had been removed.There was a photograph of ten closed clips that had obviously been removed.The ten clips were of various sizes and all seemed appropriately closed.The final photograph was of the patient¿s neck which showed a fresh transverse neck incision with a drain in situ, coming out the right side of the wound.There was tegaderm covering the incision.There was some hollow deformity or scar in the midline above the surgical wound.Based on the photo, no conclusion could be reached as to what may have caused the reported incident, the assignable cause of the reported complaint could not be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned, our evaluation is limited.As part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.
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Manufacturer Narrative
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(b)(4).Date sent: 6/23/2021.H2: additional information received: medical records attached to medwatch report: progress notes 10-7-2019.Office visit to surgeon 10-13-2019.
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Manufacturer Narrative
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(b)(4).Date sent: 6/23/2021.H2: additional information received from patient (or consumer): the first surgeon on (b)(6) 2015 never mentioned the clips in my surgery report.Never.On (b)(6) 2021, doctor removed the nasty clips.He removed 10 clips of my ¿sphofago.¿ doctor never gave me the nasty clips although i asked for the clips, doctor did not give them to me.He told me they had to be sent for a pathology.Many of the clips looks like "rusted" with different shapes and different sizes (a photo review by ethicon medical safety of previously received photo showed ¿a photograph of ten closed clips that had obviously been removed.The ten clips were of various sizes and all seemed appropriately closed.¿ review was detailed in (b)(4).Operative notes: on (b)(6) 2015: thyroidectomy on (b)(6) 2015.Female; birthdate: on (b)(6) 1964.Pre/post-op diagnosis: papillary thyroid cancer on needle biopsy (right thyroid nodule).Progress notes from office visit on (b)(6) 2019: patient reports painful swallowing and choking sensation since thyroidectomy in 2015.She tried 6 mos of omeprazole without improvement.She takes tylenol and motrin for the pain.She had post-surgical ct neck and chest with contrast, no abnormality found.She also underwent mri which was read as negative.Ultrasound on (b)(6) 2019, did not show any masses, lesions, or lymphadenopathy ent reports show she was treated with ppi (proton pump inhibitor for concern for lpr (laryngopharyngeal reflux).Due to her ¿choking¿ and dysphagia, she was referred for gi workup of silent reflux but patient did not pursue this patient reports undergoing two prior swallow studies (records not available for review) but was told they were normal.She underwent laryngoscopy, stroboscopy, and referral to slp (speech or language therapy) by outside ents without improvement.Pain is present for over 4 yrs now without improvement.Patient denies pain like this prior to her surgery (thyroidectomy).Office visit to surgeon on (b)(6) 2019: patient reports ever since her thyroidectomy, she has had tight uncomfortable feeling in her neck which is not altered with movement.She reports shortness of breath (dyspnea).Vocal cords checked by ent doctors (3 docs) and cords are okay.They say pharyngeal redness.They thought she could have silent reflux, omeprazole did not help.Neck exam by surgeon on (b)(6) 2019 showed no masses or nodes.Has appt.For gi evaluation.She had swallow study done on (b)(6) 2017.On (b)(6) 2018, had neck ultrasound showing benign nodes.Ct on (b)(6) 2018, no masses in thyroid bed and no worrisome lymph nodes.Surgeon does not feel hemoclips were her issue.He stated if clip was issue and was irritating a nerve, he would not expect her to have bilateral symmetric pain as she points out when she grabs both sides of her neck.He emphasized to patient clips were not the cause of her difficulty.Surgeon does not recommend removal of clips as he felt would lead to more problems.Surgeon suspects patient discomfort may be related to scarring and at this point is likely permanent.Patient had some of clips surgically removed from neck on (b)(6) 2021.Pathology report on (b)(6) 2021: skin with underlying scar.One of two lymph nodes shows metastatic papillary thyroid carcinoma.Fibroconnective tissue with suture material -an associated foreign body-type reaction and chronic inflammation.And metallic surgical clips for gross identification only.Medical records attached to medwatch report: operative report.3 days post op visit.
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Manufacturer Narrative
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(b)(4).Date sent: 6/23/2021.H2: additional information received: medical records attached to medwatch report: x-rays.
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