MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

ETHICON ENDO-SURGERY, LLC. LIGACLIP EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Catalog Number LTXXX

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Depression (2361); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type Injury

Manufacturer Narrative

(b)(4).Batch # unk.Maude report number: mw5098486-1.The lot/batch and device product code were not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain additional information.

Event Description

It was reported by the patient that "use of surgical clips in my partial thyroidectomy has left me in chronic pain.Poking, sharp sensation with each swallow.Soreness, irritation.Surgeons need to stop using them.Suicidal from clip pain.Chronic pain/md depression.People are suffering from these clips put in them without their knowledge.They are known to migrate and can cause pain being that they are foreign bodies.Just because a titanium clip is "inert" doesn't mean it's not pressing on or irritating a nerve or placed wrong.And surgeons should be held accountable for not disclosing this important fact (lack of informed consent) to a patient before inserting clips.I will get the model and maker soon.Why are titanium surgical clips allowed to be used in thyroid surgery? many people, including me, are suffering from a foreign body sensation in their neck/throat from these clips.I have four inserted in me which i was not told about before surgery (lack of informed consent) and i can feel them poking at me all day when swallowing and moving my head around.How dare surgeons be allowed to insert these without informing patients beforehand.Clips being called a "standard of care" needs to be updated.Maybe they were "standard of care" back in the old days, but not these days.Sutures and/or cauterization is used as well these days which should be the norm.Many people have many more clips in their neck than i do.Some feel them, some don't.The word "inert" means nothing when these horrible pieces of metal are rubbing/scraping/poking inside you and/or touching on nerves in the neck.I'm tired of doctors saying it's rare to feel these things.How do they know? do they have clips in their neck? some surgeons say it is possible though to feel them.It's rare because no one speaks up about them.Clips ought to be banned from use in thyroid surgery.Sutures or cauterization can be used instead.(b)(6) clips in my neck after total thyroidectomy has posts of many people suffering from these clips.One lady in had 25 in her neck after thyroid surgery and had to wait 18 months of suffering to find a willing surgeon to remove them.Removing them.They can remove your thyroid, with possible complications, but not some clips? huh? or they just don't want to remove them, don't have the confidence/skill needed to or don't care if the patient is suffering from them.Luckily i have found a good surgeon who is willing to remove these four horrible clips from my neck.I have to fly from for this surgeon and undergo another surgery to get these things out of me.It's been the worst time of my years of life and i pray i make it through.I am married and have two teen boys i'd love to watch grow up and who need me.How about the fda look into this subject? when i get these out of me, i will have the surgeon save them for me for evidence.This reminds me of breast implants.It's taken some 30 years for the fda, doctors, etc.To admit they are causing problems in women with bll.We'll duh.They are a foreign body just like titanium surgical clips.".

Manufacturer Narrative

(b)(4).Date sent: 5/19/2021.Investigation summary: this following is a review of a photo that was submitted for evaluation.The review that was performed by an ethicon medical safety officer is as follows: "i reviewed a photograph of a computer screen showing a lateral neck xray of patient referred to in this complaint.Relevant to the complaint were 3 small closed metallic clips in the anterior part of the neck.The surgical clips appeared appropriately closed." 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.

Manufacturer Narrative

(b)(4).Date sent: 4/23/2021.H10: maude report number: mw5098486-1.H2: additional information received: consumer reports ""hello i don't have the product code of the clips.The surgeon who put these things in me, without my knowledge/consent, doesn't even seem to know.If you can find out, i would love to know what clip applier was used and the product code.Can you please email me that information, if you get it.It's not in the operative report.Yes, i have all my medical records.Piles and piles.I will send another separate email with the operative report stating only, 'clips were placed.' yes, you have my permission to speak with my surgeon.I have to fly to a different state to get these things removed." consumer provided operative notes, post-op visit notes, neck x-ray, and x-ray report.Records are redacted and attached to this medwatch and follow up medwatches.Op-notes page 1 attached to this report.Post-op visit notes from (b)(6) 2020 and (b)(6) 2021.Describe the following: h6: health effect clinical codes: appropriate term/code not available (e2402): swallowing issue; upper esophageal sphincter pressure/hypertensive upper esophageal sphincter on manometry; esophageal dysmotility; cervical globus sensation; dysphagia; dry sensation in neck.H6: health effect impact code: medication required (f2303); desipramine; robaxin; lorazepam.

Manufacturer Narrative

(b)(4).Date sent: 5/6/2021.H2: additional information received: this is an analysis for a photo submitted for evaluation.During the visual analysis, the following was observed: the photo shows an x-ray with what appear to be clips present.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.

Manufacturer Narrative

(b)(4).Date sent: 5/19/2021.H2: additional information: this following is a review of a photo that was submitted for evaluation.The review that was performed by an ethicon medical safety officer is as follows: "i reviewed a photograph of a computer screen showing a lateral neck xray of patient referred to in this complaint.Relevant to the complaint were 3 small closed metallic clips in the anterior part of the neck.The surgical clips appeared appropriately closed." 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.

Manufacturer Narrative

(b)(4) date sent: 4/23/2021 h10: maude report number: mw5098486-1 h2: additional information received: consumer provided operative notes, post-op visit notes, neck x-ray, and x-ray report.Records are redacted and attached to this medwatch and follow up medwatches.Op-notes page 4 attached to this report.

Manufacturer Narrative

(b)(4)a date sent: 4/23/2021 h10: maude report number: mw5098486-1 h2: additional information received: consumer provided operative notes, post-op visit notes, neck x-ray, and x-ray report.Records are redacted and attached to this medwatch and follow up medwatches.Op-notes page 3 attached to this report.

Manufacturer Narrative

(b)(4).Date sent: 4/23/2021 h10: maude report number: mw5098486-1 h2: additional information received: consumer provided operative notes, post-op visit notes, neck x-ray, and x-ray report.Records are redacted and attached to this medwatch and follow up medwatches.Op-notes page 6 below (pdf verbiage converted to word document due to failed pdf attachment): (b)(6) frozen section analysis revealed the fmdings of a benign thyroid nodule.Furthermore the biopsy of the parathyroid gland revealed nonnal parathyroid tissue.E autotransplanted the right upper parathyroid gland into the left sternocleidomastoid muscle.The left inferior anterior stemocleidornastoid muscle was exposed.A tonsil clamp was used to make 2 adjacent pockets in the muscle approximately centimeter half feet from the anterior muscle surface.At the opening of each pocket of figure-of-eight 4-0 --prolene suture was placed but not yet tied.From the back table the parathyroid gland was cut into multiple small less than 1 rrnn fragments of tissue with a 15 blade.The specimen was separated into 2 equal parts and each part was placed into each respective muscle pocket once the specimen was placed into each muscle pocket the figtrre-of-eight suture was tied thereby sealing the pocket.A clip was placed on the knot of the suture to help mark the location of the transplantation.The right neck was irrigated with sterile saline.We made sure that hemostasis was intact.The strap muscles were then closed vertically with interrupted 3-0 vicryl sutures.The alexis retractor was reinoved.The platysma was then closed transversely hack together with interrupted 4-0 :.Vicryl sutures.The ski11is closed with a running 5-0 monocryl --- subcuticular suture.Steri-strips and sterile dressings were applied.Atient was then awakened inthe operating room extubated and taken to the postanesthetic recovery unit with good condition with stable vital.

Manufacturer Narrative

(b)(4).Date sent: 4/23/2021.H10: maude report number: mw5098486-1.H2: additional information received: consumer provided operative notes, post-op visit notes, neck x-ray, and x-ray report.Records are redacted and attached to this medwatch and follow up medwatches.Office visit notes pages from dec 23, 2020 and jan 27, 2021 (pdf verbiage converted to word document due to failed pdf attachment): ! 12/23/2020 : · the patient is a 47-year-old woman who was seen in follow u er previously having a right hemithyroidectomy with ,.---' utotransplantation of one of her parathyroid glands into h right temocleidomastoid muscle.One of the preoperative complaints ·as that the patient had a feeling of choking and pressure in neck.She had a fairty sizable thyroid mass and it was suspected 1.At this may contribute to her symptoms.Despite surgery she still has persistence of some of the symptoms.She currently is feeling a little bit better.She has noted that she has been seen in the emergency department for her complaints a number of times.She now complains of a "poking" neck pain.The patient had reviewed her operative report and noted that we used hemoclips to place on the superior thyroid artery and also to denote the location of the parathyroid autotransplantation.She is concerned that these clips could be causing her symptoms of pain.She wanted to know if iwould be wiffing to explore her neck to take those clips out.The patient did have esophageal manometry and she was found to have a markedly elevated upper esophageal sphincter pressure.In addition she has 50% of her swallows are failed.She dearty has esophageal dysmotility and ithink that explains a lot of the symptoms that she has such as the globus sensation and the difficulty with her swallowing.01/27/2021 : patient presents for further evaluation regarding right-sided neck pain.She states she has a poking/dry sensation in her right neck, perceives the need for moisture in the area.She notes that the pain is up high in the submandibular area as well as in the lower right neck.' f\j6t ct 1 <.: k n ee( 1 since the last visit the patient saw the gastroenterologist and she wa noted to have hypertensive upper esophageal sphincter on manometry.She stated that the gastroenterologist was not "v im ed" with the hypertensive esophageal manometry findings.I do not have any documentation as to that interaction.The patient does note though that the patient was given a prescription for desipramine and she is only taken a few doses so far.She was also given a prescription for robaxin.S.Ije previously took gabapentin without help.She does take lorazepam and she states that that helps quite a bit.The patient is fixated on the possibility that the hemodips used to seal blood vessels in her thyroid surgery are the cause of her neck pain.The patient also saw a pain medicine specialist and she states that the pain medication specialist discussed performing a cervical plexus block to see if that would help her symptoms.The patient has decided that she will wait at least an year from the time of her ros: patient reports no sore throat, no bleeding gums, no snoring, no dry mouth, no mouth ulcers, no oral abnormalities, and no teeth ,.-qj:oblems; tmj pain.She reports constipation but reports no abdominal pain, no nausea, no vomiting, normal appetite, no 1rrhea, not vomiting blood, no dyspepsia, and no gero.She reports anxiety but reports no depression, no sleep disturbances,.Eling safe in a relationship, no alcohol abuse, no hallucinations, and no suicidal thoughts.She reports no fever, no night sweats, no significant weight gain, no significant weight loss, and no exercise intolerance.She reports no dry eyes, no vision change, and no irritation.She reports no difficulty hearing and no eat pain.She 'l'eports no frequent nosebleeds, no nose problei'l"ls, and no sinus problems.She reports no chest pain, no arm pain on exertion, no shortness of breath when walking, no shortness of breath when lying down, no palpitations, and no known heart murmur.She reports no cough, no wheezing, no shortness of breath, no coughing up blood, and no sleep apnea.She reports no incontinence, no difficulty urinating, no hematuria, and no increased frequency.She reports no muscle aches, no muscle weakness , no arthralgiasfjoint pain, no back pain, and no swelling in the extremities.She reports no abnormal mole, no jaundice, no rashes, and no laceration.She reports no loss of consciousness, no weakness, no numbness, no seizures, no dizziness , no migraines, no headaches, and no tremor.She reports no fatigue.She reports no swollen · glands, no bruising, and no excessive bleeding.She reports no runny nose, no·sinus pressure, no itching, no hives, and no frequent sneezing.Physical exam patient is a 47-year-old female.Constitutional :general appearance : healthy-appearing, well-nourished, and well-developed.Level of distress: no acute distress.Ambulation : ambulating normally.Head:head: normocephalic and atraumatic; voice is normal.Neck:neck: supple, trachea midline, no masses, and full range of motion.Thyroid: no enlargement or nodules and non-tender; low transverse neck scar-healing well.Lymph nodes: no cervical lad.Cardiovascular: heart auscultation: normal s1 and s2; no murmurs, rubs, or gallops; and regular rate and ,---r--h._ythm.Nga:respiratory effort: no dyspnea.Auscultation : no wheezing, rales/crackles, or monchi and breath sounds normal,.Good air movement, and clear to auscultation.Skin:lnspection and palpation: good turgor and no jaundice.Imaging notes 1-22-2021 from wave imaging below: wave imaging - laguna woods 24301 paseo de valencia suite 100 laguna woods, ca 92637 phone: (949) 462-3999 fax: (949) 462-3777 ordered by bernard elpedes, do 22855 lake forest dr, ste a lake forest ca, 92630 fax: (949) 770-2679 date of service: 01-22-2021 exam: x-ray soff tissue neck idstory: status post thyroid nodule removal.Technique : ap and lateral view of the neck soft tissue was obtained.Comparison : none available.Findings the adenoids and epiglottis: normal in size.The airway : patent.There is no evidence of paravertebral soft tissue swelling.Visualized cervical spine is unremarkable.Four radiopaque surgical clips are seen in the region of thyroid, following surgery.Impression: i.Four radiopaque surgical clips are present in the region of thyroid, following surgery.2.Unremarkable examination of the soft tissues of the neck.Confidential.

Search Alerts/Recalls

New Search | Submit an Adverse Event Report

Brand Name

LIGACLIP EXTRA TITANIUM CLIPS

Type of Device

CLIP, IMPLANTABLE

Manufacturer (Section D)

ETHICON ENDO-SURGERY, LLC.

475 calle c

guaynabo 00969

MDR Report Key

11679623

MDR Text Key

246357827

Report Number

3005075853-2021-02063

Device Sequence Number

Product Code

FZP

Combination Product (y/n)

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,other

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

04/16/2021

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Catalogue Number

LTXXX

Was Device Available for Evaluation?

Date Manufacturer Received

05/10/2021

Patient Sequence Number

Patient Outcome(s)

Other;

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Links on this page:

Links on this page: