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

Model Number 176657

Device Problems Misfire (2532); Failure to Fire (2610)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2021

Event Type  malfunction  

Event Description

Per surgeon: "misfires, doesn't fire and clips fly off in all directions when being deployed, the retention of the clip is frequently pathetic".Fda safety report id# (b)(4).

• Brand Name: ENDO CLIP II AUTO SUTURE
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11528995
• MDR Text Key: 241454121
• Report Number: MW5100117
• Device Sequence Number: 1
• Product Code: FZP
• 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: 03/16/2021

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 Model Number: 176657
• Device Catalogue Number: 176657
• Device Lot Number: 2720029853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1