MAUDE Adverse Event Report: COVIDIEN SURGICAL LAPRO-CLIP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	8886848700
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, prior to use, the inner axle of the applier was bent and would fall from the top.The handle was also sha king.Another clip applier was used to resolve the issue.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: d4 (lot), d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted a hole on the exterior shaft.When disassembled, the internal pin was noted as disengaged.The distal end of the internal shaft was noted as bent.It was reported that prior to use, the inner axle of the applier was bent.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the instrument is applied improperly during application or reassembled improperly after sanitizing.It was also reported that prior to use, the inner axle of the applier fell from the top.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the instrument due to improper handling during reinsertion of the internal shaft.The evaluation detected an unreported condition of mismatched shaft numbers.The most likely cause for the additional condition is a maintenance issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: reusable devices must be carefully inspected prior to and after each use, as any damage may affect the safe operation of the device.Failure to lubricate the device prior to sterilization may cause malfunctions such as jamming, difficult operation, or unacceptable staple formation.During assembly push the handle forward.Replace the inner shaft assembly taking care that all grooves are aligned between the handle, inner shaft, and rotating shaft.Top view of grooves.Pull the handle back and replace the end cap.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 SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22928924
• Report Number: 1219930-2025-03835
• Device Sequence Number: 21122754
• Product Code: GCJ
• UDI-Device Identifier: 10884521057623
• UDI-Public: 10884521057623
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: 8886848700
• Device Catalogue Number: 8886848700
• Device Lot Number: C3A3174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown