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

Model Number 8886848813

Device Problems Device Slipped (1584); Failure to Fire (2610); Firing Problem (4011)

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

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic cholecystectomy, on ligation of bile duct, the clip formed but was not able to clip on the vessel and taken out with the applier together.None of the clips disengaged from the cartridge.They opened a new device to complete the case.There was no patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

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

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 06473
• MDR Report Key: 7767940
• MDR Text Key: 116879304
• Report Number: 1219930-2018-04364
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521057668
• UDI-Public: 20884521057668
• 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,Followup,Followup
• Report Date: 10/21/2019

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 Expiration Date: 01/31/2023
• Device Model Number: 8886848813
• Device Catalogue Number: 8886848813
• Device Lot Number: N8A0016X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 08/08/2018; 10/02/2019
• Supplement Dates FDA Received: 10/04/2018; 09/29/2019; 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1