MAUDE Adverse Event Report: COVIDIEN ENDO CLIP III AUTO SUTURE CLIP APPLIER 5MM; CLIP, IMPLANTABLE

Catalog Number 176630

Device Problem Misfire (2532)

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

Event Date 04/15/2022

Event Type  malfunction  

Event Description

During laparoscopic cholecystectomy, the endo clip iii auto suture clip applier with clip logic technology misfired multiple times.

• Brand Name: ENDO CLIP III AUTO SUTURE CLIP APPLIER 5MM
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 14195588
• MDR Text Key: 290116620
• Report Number: MW5109339
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 176630
• Device Lot Number: J1K0088Y
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White