MAUDE Adverse Event Report: COVIDIEN LLC COVIDIEN PREMIUM SURGICLIP II AUTO SUTURE; CLIP IMPLANTABLE

Lot Number P8H1762CX

Device Problems Defective Device (2588); Activation Problem (4042)

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

Event Date 11/06/2018

Event Type  malfunction  

Event Description

During liver resection surgery attempted to use a large covidien hemoclip applier and it malfunctioned not deploying a clip.Another attempt made with same result.These were the only uses of product - it was passed off field - labeled as defective.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN PREMIUM SURGICLIP II AUTO SUTURE
• Type of Device: CLIP IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LLC; mansfield MA 02048
• MDR Report Key: 8586523
• MDR Text Key: 144412859
• Report Number: MW5086400
• 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: 05/02/2019

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 Expiration Date: 08/31/2023
• Device Lot Number: P8H1762CX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2019
• 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: 69 YR
• Patient Weight: 66