MAUDE Adverse Event Report: COOPERSURGICAL / FEMCARE LTD. FILSHIE TUBAL LIGATION SYSTEM; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Lot Number 38901

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2020

Event Type  Injury  

Event Description

A (b)(6) y/o g3 para 2 at (b)(6) weeks gestation with failure to progress.C-section performed with scheduled tubal ligation.Low transverse incision.With delivery of viable infant.Filshie clips placed.When drapes were removed, an open filshie clip was noted on the drape.Surgeons present during procedure verified that the clips were placed bilaterally with blanching noted.X-ray completed which verified only one clip present on the right fallopian tube.Patient was re-draped and incision opened.The left tube was inspected and noted to be intact with no signs of damage or indication that the clip had been placed previously.Clip placed on left tube and incision was closed.No post procedure complications were noted.

• Brand Name: FILSHIE TUBAL LIGATION SYSTEM
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPERSURGICAL / FEMCARE LTD.
• MDR Report Key: 10173797
• MDR Text Key: 195978728
• Report Number: MW5095078
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Lot Number: 38901
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 32