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

Model Number	8886848808
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2018
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, during a laparoscopic total gastrectomy, on ligating the vessel, the clip cartridge was not able to be properly loaded onto the handle; the clip did not disengage from the cartridge and did not form correctly.The inner and outer parts of the clip separated.They changed to another clip to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the photo noted; the clip body disengaged from the cartridge and the tracks were not inserted properly at the distal end of the clip body.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the observed condition may occur if the clip was not properly applied and mishandled during the clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of six devices.The visual inspection of the cartridges noted two were fully applied, one clip body was disengaged and the tracks were not inserted properly at the distal end of the clip body.Visual inspection of the other four cartridges noted they were not applied.The clip body and tracks were reassembled and reinserted into one of the two cartridges.A pmv representative instrument was used for all functional testing.The cartridge was loaded into the pmv representative instrument, the firing handle was actuated, and the clip formed properly onto the test media.The four cartridges were loaded into the pmv representative instrument, the firing handle was actuated, and the four clips formed properly onto the test media.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the observed condition may occur if the clip was not properly applied and mishandled during the clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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: 7903291
• Report Number: 1219930-2018-05190
• Device Sequence Number: 11151054
• Product Code: GCJ
• UDI-Device Identifier: 10884521057647
• UDI-Public: 10884521057647
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K925602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2019

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 Expiration Date: 05/31/2023
• Device Model Number: 8886848808
• Device Catalogue Number: 8886848808
• Device Lot Number: N8E0833X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2018
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 11/30/2018; 05/22/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 12/28/2018; 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1