MAUDE Adverse Event Report: COVIDIEN PROTACK; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	174006
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	10/06/2025
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, intraoperatively, while the surgeon was firing the tacker, a tack was stuck in the device and came out halfway which cause the patient¿s tissue to tear when the surgeon tried to remove the tack.
Additional Manufacturer Narrative
Additional information: b5, 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 that the inner components of the instrument revealed no abnormalities.No tacks were observed in the shaft.Functional testing found that the handle was cycled with acceptable results.It was reported that a tack was stuck.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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, intra-operatively, while the surgeon was firing the tacker, a tack was stuck in the device and came out halfway which cause the patient¿s tissue to tear when the surgeon tried to remove the tack.Another device was used to complete the case.

• Brand Name: PROTACK
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23394397
• Report Number: 2647580-2025-03210
• Device Sequence Number: 18653801
• Product Code: GCJ
• UDI-Device Identifier: 10884521070400
• UDI-Public: (01)10884521070400(17)290831(10)P4J1039
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K090470
• 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): 01/13/2026

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: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P4J1039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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