MAUDE Adverse Event Report: COOPERSURGICAL INC. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Malposition of Device (2616)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Fatigue (1849); Hemorrhage/Bleeding (1888); Hot Flashes/Flushes (2153); Tingling (2171); Dizziness (2194); Arthralgia (2355); Numbness (2415); Palpitations (2467); Abdominal Distention (2601)

Event Type  Injury  

Event Description

I had bilateral tubal ligation in 2013 and started to have symptoms in (b)(6) 2016 of severe stabbing abdominal pain, leg and joint pain, numbness and tingling of my legs, and severe bloating.Later symptoms included dizziness, hot flashes, palpitations, severe fatigue, vaginal bleeding.These symptoms developed over a year time.I followed up with my pcp and went for some x-rays, incidentally, was found to have a displaced filshie clip in my left upper abdomen.My right clip was missing while my left one was still intact.My left clip was removed which my dr told me that it was sitting on a major nerve.She was not able to get the displaced clip as it was too high and i was to see general surgery.I've had on and off little pinpoint chest pain there until about a month ago i had chest pain for 4 days without any relief.I went to the urgent care and my cardiac work up came back negative.I followed up with my pcp and she wanted to localize the pain.I got another ct scan, everything was negative and the filshie clip sits between my spleen and splenic flexure.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPERSURGICAL INC.
• MDR Report Key: 8970873
• MDR Text Key: 157329380
• Report Number: MW5089611
• Device Sequence Number: 0
• Product Code: KNH
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Life Threatening
• Patient Age: 36 YR
• Patient Weight: 73