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

Model Number 133650

Device Problem Misfire (2532)

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

Event Date 01/26/2023

Event Type  malfunction  

Event Description

Premium surgiclip iii, lot# p2l0564, reference# 133650, expiration date [redacted date].Device is misfiring.Ejects small clips every other round instead of every round.Material management notified.

• Brand Name: PREMIUM SURGICLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 16551882
• MDR Text Key: 311401834
• Report Number: 16551882
• Device Sequence Number: 1
• Product Code: FZP
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 133650
• Device Catalogue Number: 133650
• Device Lot Number: P2L0564
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1