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

Catalog Number AVM 851

Device Problems Positioning Failure (1158); Defective Device (2588)

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

Event Date 12/16/2016

Event Type  malfunction  

Event Description

Per the operative report, during tubal ligation, after two attempts, the filshie clips were found to be defective and not deploying.They were removed and we proceeded with a kleppinger.Surgeon incidentally performed tubal ligation by use of the kleppinger bipolar cautery.

• Brand Name: FILSHIE
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 6453061
• MDR Text Key: 71517136
• Report Number: 6453061
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: AVM 851
• Device Lot Number: 36083
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR