MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN COVIDIEN SURGICLIP M 11.5; CLIP, IMPLANTABLE

Model Number 134031

Device Problem Failure to Form Staple (2579)

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

Event Date 03/03/2020

Event Type  malfunction  

Event Description

Clips did not close.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN SURGICLIP M 11.5
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC / COVIDIEN ; minneapolis MN 55432
• MDR Report Key: 9810767
• MDR Text Key: 183118722
• Report Number: MW5093629
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 134031
• Device Catalogue Number: 134031
• Device Lot Number: PG13924
• 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: 66 YR