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

Model Number 176620

Device Problems Mechanical Problem (1384); Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, while being applied in clipping the cystic duct and artery and removing the specimen during a laparoscopic cholecystectomy, the clips were not fully closed or secure, and were falling off the duct/artery.The bag tore at the seam completely open and the specimen fell back into the cavity.There was very little tension put on the bag before it ripped.The surgeon spent a significant amount of time trying to find and retrieve the specimen and clips.Another bag was used and fire more clips to complete the case.This resulted to extended surgical time of more than 30 minutes.There was no patient injury.

• 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: 9141908
• MDR Text Key: 160779902
• Report Number: 1219930-2019-05486
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521057876
• UDI-Public: 10884521057876
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 176620
• Device Catalogue Number: 176620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2019
• 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