MAUDE Adverse Event Report: COVIDIEN SURGICLIP III APPLIER; CLIP, IMPLANTABLE

Catalog Number 133650

Device Problem Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2023

Event Type  malfunction  

Event Description

Covidien premium surgiclip iii clip applier (9.0" small).Reference 133650, lot p2m0004, exp 2027-11-30; continuously misfiring throughout critical times.This happened with 2 pts same day.Ref report: mw5114896.

• Brand Name: SURGICLIP III APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 16371018
• MDR Text Key: 309563887
• Report Number: MW5114895
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 133650
• Device Lot Number: P2M004
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2023
• Patient Sequence Number: 1