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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Date 06/24/2016

Event Type  Injury  

Event Description

I underwent tubal ligation on (b)(6) 2009.Unbeknownst to me a filshie clip was placed instead of the coagulation method that i agreed to.Informed consent on use of clip was not obtained.I began having pelvic pain a few years later.Multiple ultrasounds were done with negative findings (records unobtainable).Mri was done in early 2016 also not showing a filshie clip.On (b)(6) 2016 exploratory laparoscopy and bilateral salpingectomy was done.One of the tubes still had a clip attached, the other did not.Pelvic pain returned a little over a year later and i underwent another laparoscopic procedure.This time the missing filshie clip was found behind my cervix.Review of previous procedure shows surgeon had been working in this area back in 2016 and clip was not there.Surgeon did spend time looking for missing clip at the time.The clip had been migrating around the peritoneal cavity for many, many years.Extensive adhesions were found during both procedures.The clip could have been the cause of pelvic pain, adhesions, possible foreign body and / or allergic reaction (i am allergic to many metals and never would have consented to having a metal device in my body, even possibly contributed to development of endometriosis.No testing was done other than gross pathology exams showing the clip was submitted.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 8707656
• MDR Text Key: 148463220
• Report Number: MW5087415
• Device Sequence Number: 1
• Product Code: KNH
• 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: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 38 YR
• Patient Weight: 61