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

Model Number	8886848882
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the event occurred with the first packet.Even though there was no problem with loading the cartridge, when firing the clips in a laparoscopic cholecystectomy, the clips didn¿t deploy well for 3 times consecutively.The procedure was completed with another device.There was no patient injury.
Additional 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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LAPRO-CLIP
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8016291
• Report Number: 1219930-2018-05730
• Device Sequence Number: 1352822
• Product Code: GCJ
• UDI-Device Identifier: 10884521057678
• UDI-Public: 10884521057678
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K925602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 8886848882
• Device Catalogue Number: 8886848882
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1