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

Model Number	8886848882
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 8886848882 - 8886848882 laproclip 2x8mm x10, lot# n4d2343y.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a laparoscopic procedure, when the surgeon tried to use the device, the two cartridges were distorted and could not be used it is unknown whether the device was distorted during usage or before use.A new device was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection of the cartridge was applied with the clip body disengaged and the tracks were not inserted properly at the distal end of the clip body.Functionally, the clip body and tracks were reassembled and reinserted into the cartridge.A representative instrument was used for all functional testing.The cartridge was loaded into the representative instrument, the firing handle was actuated, and the clip formed properly onto the test media.It was reported that a clip formation occurred.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the clip was not properly applied during the application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: failure to fully squeeze the handle may result in miss-formed clips which may result in incomplete closure and lack of hemostasis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20810759
• Report Number: 1219930-2024-05599
• Device Sequence Number: 9302515
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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
• Device Lot Number: N4D2343Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown