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

Model Number 5MM SINGLE INCISION APPLICATOR

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2020

Event Type  malfunction  

Event Description

During surgery the physician clipped the filshie clip device onto the fallopian tube and a piece of the tip of the device broke off.

• Brand Name: FILSHIE CLIP APPLICATOR
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): FEMCARE LIMITED; 7043 south 300 west; midvale UT 84047
• MDR Report Key: 11018846
• MDR Text Key: 221765770
• Report Number: 11018846
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/07/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5MM SINGLE INCISION APPLICATOR
• Device Catalogue Number: AVM-880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1