MAUDE Adverse Event Report: FEMCARE LIMITED FILSHIE® CLIPS; DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number	TWENTY PAIR STERILE FILSHIE CLIPS
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Physician was going to use the filshie clips to perform a bilateral tubal ligation.One of filshie clips would not clasp.Physician had to instead perform a standard bilateral tubal ligation using sutures.

• Brand Name: FILSHIE® CLIPS
• Common Device Name: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): FEMCARE LIMITED; utah medical products, inc.; 7043 south 300 west; midvale UT 84047
• MDR Report Key: 8292504
• Report Number: 8292504
• Device Sequence Number: 1203358
• Product Code: HHS
• UDI-Device Identifier: 05055515602121
• UDI-Public: (01)05055515602121
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2019
• Report Date (Section F): 01/15/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TWENTY PAIR STERILE FILSHIE CLIPS
• Device Catalogue Number: AVM-851
• Device Lot Number: 38395
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/15/2019