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

Catalog Number 176630

Device Problem Firing Problem (4011)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2020

Event Type  malfunction  

Event Description

Endo clip applier ref# 176630 from covidien was periodically firing sideways.The surgeon used the clips he could from the applier.There was no pt harm.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN ENDO CLIP III 5MM
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9799405
• MDR Text Key: 182544495
• Report Number: MW5093546
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 176630
• Device Lot Number: J9L2600Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2020
• 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: 49 YR