MAUDE Adverse Event Report: COVIDIEN ENDOCLIP III AUTOSUTURE - CLIP APPLIER W/CL; CLIP, IMPLANTABLE

Model Number 176630

Device Problem Activation Failure (3270)

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

Event Date 06/08/2021

Event Type  malfunction  

Event Description

The 5mm endoclip applier failed to deploy the clip during surgery.Another clip applier obtained.Defective clip applier in my office for risk management to obtain.No patient harm.Fda safety report id # (b)(4).

• Brand Name: ENDOCLIP III AUTOSUTURE - CLIP APPLIER W/CL
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12107852
• MDR Text Key: 260092570
• Report Number: MW5102257
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: 10884521057852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J0H2831Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 65 YR