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	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During tubal ligation, the filshie clip applicator was inserted and filshie clip was attempted to be deployed, but it would not lock on the tube.Three other filshie clips were tried and none of them would lock on the tube.Surgeon attempted to close and engage the clips outside the body, and they would not engage.

• Brand Name: FILSHIE CLIPS
• Common Device Name: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): FEMCARE LIMITED; 7043 south 300 west; midvale, UT 84047
• MDR Report Key: 9574379
• Report Number: 9574379
• Device Sequence Number: 16904838
• Product Code: KNH
• UDI-Device Identifier: 05055515602121
• UDI-Public: (01)05055515602121
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/21/2019
• Report Date (Section F): 12/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: TWENTY PAIR STERILE FILSHIE CLIPS
• Device Catalogue Number: AVM-851
• Device Lot Number: 37920
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2020
• 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: 12/21/2019