MAUDE Adverse Event Report: UNKNOWN FORCEPS

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Type  Injury  

Event Description

Ivc filter retrieval case, physician used forceps and removal required significant force and pulling, contributing to a tear that resulted in the patient's death.No spectranetics/philips devices were used during the procedure.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FORCEPS
• Type of Device: FORCEPS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17488558
• MDR Text Key: 320687992
• Report Number: MW5121257
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2023

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1