MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO CLIP; CLIP, IMPLANTABLE

Model Number 176620

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 10/19/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, while the device was being applied to the tissue during a procedure, the surgeon was able to squeeze the handle and the jaws were still able to close, however the clips did not close completely.

• Brand Name: ENDO CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 9645427
• MDR Text Key: 176954419
• Report Number: 1219930-2020-00519
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 20884521057873
• UDI-Public: 20884521057873
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K954435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2020

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 Expiration Date: 10/31/2022
• Device Model Number: 176620
• Device Catalogue Number: 176620
• Device Lot Number: N7K0889CX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 01/29/2020
• Date Device Manufactured: 10/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1