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 Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2018

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 a laparoscopy-assisted distal gastrectomy, when the handle was squeezed at the third firing, the cartridge could be pressed, but the clip was not able to come out.When other cartridge was used, the clip was able to come out normally.The procedure was completed with another device.The status of the patient was reported as no problem.

Manufacturer Narrative

This event has been reassessed and found not to be associated with a serious injury or potential for serious injury with reoccurrence.Rfr code was changed to not reportable.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: 8191702
• MDR Text Key: 131225184
• Report Number: 1219930-2018-06809
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

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: 07/31/2012
• Device Model Number: 8886848700
• Device Catalogue Number: 8886848700
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 11/26/2018
• Supplement Dates FDA Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1