MAUDE Adverse Event Report: COVIDIEN ENDO CLIP II AUTO SUTURE CLIP; CLIP, IMPLANTABLE

Model Number 10MM MEDIUM/LARGE

Device Problems Defective Device (2588); Firing Problem (4011)

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

Event Date 02/13/2023

Event Type  malfunction  

Event Description

During a cholecystectomy surgery, the covidien endo clip ii auto suture clip applier fired 2 staples and malfunctioned.The surgeon attempted to rotate the device and fire again when it failed, so it was removed from the surgical site and replaced with a functioning new device.

• Brand Name: ENDO CLIP II AUTO SUTURE CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 16447100
• MDR Text Key: 310380725
• Report Number: MW5115250
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10MM MEDIUM/LARGE
• Device Catalogue Number: 176657
• Device Lot Number: 10884521057869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIPS
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White