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

Model Number UNKNOWN LAPRO-CLIP INSTRUMENT

Device Problems Mechanical Problem (1384); Failure to Form Staple (2579); Failure to Fire (2610)

Patient Problems No Consequences Or Impact To Patient (2199); 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

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: 7767932
• MDR Text Key: 116864633
• Report Number: 1219930-2018-04363
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LAPRO-CLIP INSTRUMENT
• Device Catalogue Number: UNKNOWN LAPRO-CLIP INSTRUMENT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1