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

Model Number TWENTY PAIR STERILE FILSHIE CLIPS

Device Problem Difficult to Open or Close (2921)

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

Event Date 11/11/2019

Event Type  malfunction  

Event 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
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): FEMCARE LIMITED; 7043 south 300 west; midvale, UT 84047
• MDR Report Key: 9574379
• MDR Text Key: 174510139
• Report Number: 9574379
• Device Sequence Number: 1
• Product Code: KNH
• UDI-Device Identifier: 05055515602121
• UDI-Public: (01)05055515602121
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11680 DA