MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN LAPRO-CLIP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 8886848700

Device Problem Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during laparoscopic cholecystectomy procedure, while closing the bile duct, the inner layer of the clip cannot be opened and cannot be clipped.They then used another device to resolve the issue.There was no patient injury.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LAPRO-CLIP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8560781
• MDR Text Key: 143415547
• Report Number: 1219930-2019-02646
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521057623
• UDI-Public: 10884521057623
• Combination Product (y/n): N
• PMA/PMN Number: K925602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/29/2019

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 Model Number: 8886848700
• Device Catalogue Number: 8886848700
• Device Lot Number: N6B0943X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 09/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR