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

Model Number 176630

Device Problem Failure to Advance (2524)

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

Event Date 01/14/2020

Event Type  malfunction  

Event Description

During the laparoscopic sleeve gastrectomy procedure, the covidien endo clip iii applier (ref # 176630, lot #j9f0644y) would not advance the clips (separate report).The device was replaced with a second covidien endo clip iii applier (ref # 176630, lot # j9h0886y) (this report).The device was handed up to the field but this clip applier had intermittent advancement, with continual countdown to zero.The device was replaced with a third clip applier which worked without incident.No patient harm.

• Brand Name: ENDO CLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 9962095
• MDR Text Key: 187709700
• Report Number: 9962095
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057852
• UDI-Public: (01)10884521057852(17)220731(10)J9H0886Y
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/13/2020

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: 176630
• Device Catalogue Number: 176630
• Device Lot Number: J9H0886Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Weight: 103