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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Cyst(s) (1800); Pain (1994); Cramp(s) (2193); Heavier Menses (2666)

Event Date 10/01/2019

Event Type  Injury  

Event Description

My tubal was given in 2015.Successfully as the medical notes state the filshie clips.Last year towards (b)(6) i was having problems with menstrual cramps and pain.My dr was prescribing birth control pills, which did not help.Then she tried nexplanon.I then began heavily bleeding with worsening pain for months non stop.I was having trouble functioning with the pain.I was in the hosp, given ultrasound which did not show any problems besides 2 small cysts on both sides of my uterus.I then was given estrogen pills to see if that would help.I went to an obgyn and was suggested the problem was endometriosis.But the dr informed me he couldn't diagnose that without surgery.So he suggested a partial hysterectomy but informed me that if i had endometriosis that i would eventually need a full hysterectomy if the problems persisted.I elected to do a total hysterectomy due to already being out of work due to medical leave and being a mother of 3 small children under the age of 10.I was having a hard time functioning as it was as a mother, and as a human being and did not want to have to go in surgery more than once.In surgery the dr did not find any endometriosis.The left filshie clip could not be located.The right filshie clip had migrated, was deteriorating and located in my uterus - ovarian ligament.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: 9785727
• MDR Text Key: 182512168
• Report Number: MW5093495
• 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: 03/01/2020

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: 03/03/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 27 YR
• Patient Weight: 73