MAUDE Adverse Event Report: UNKNOWN TITANIUM CLIPS; CLIP, IMPLANTABLE

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Date 07/22/2020

Event Type  Injury  

Event Description

I am concerned about titanium clips (with sharp edges) that are left in the liver after gallbladder removal laparoscopic surgery.I have them in since my surgery 12 years ago but was not advised that they will be left there.I have permanent pain in that area and was asking different health care professional about it, but without any luck.I know that mine are two sizes too big, and that my pain is related to having them in.I have sharp pain in my upper right abdomen that started right after surgery, and every day since the surgery have it.It has been heavier at times, and specifically harsh after running, or while driving with bumps in the road.I am almost losing conscience how deep it hits me like a needle right in my liver or diaphragm.These clips are made of titanium, so there are no immunologic or any biologic response to having them, and for most people, they may not be felt or have an effect in the body.This is not the case with me.Not only that i have constant pain, no one in medical field thinks that these clips may cause pain.And that is because there are no studies that follow women after gallbladder removal surgery and asks about it.And women specific, because women bodies are in general smaller than men, and there is a possibility that even though there are three sizes of clips, even the smaller one may be too big.I am constantly dismissed in health offices suggesting that my pain comes from gi disturbances, muscle strains, pack pain, which are all just the best guesses.I do not understand why people thinks that these clips could not be felt? gallstones that are typically smaller and round are noticed in the body, and instead of letting that spot be object-free, the medical community felt that placing clips would not lead to pain, or other sensations at this place.Permanent pain.No one test can tell you when and why there is pain, but ever since i got these clips in me, i know that i have them, and i think that there are thousand people around with the same problem that are being dismissed, but they should not be.I am working for fda, in cder, oce, dhot, and i would like to talk with someone who covers tool like this in surgery.Sincerely, (b)(6), phd (b)(6).Do not know, but it's still in me.Fda safety report id #: (b)(4).

• Brand Name: TITANIUM CLIPS
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10350040
• MDR Text Key: 201421925
• Report Number: MW5095828
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR