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

Model Number	174006
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: 174006, 174006 protack 5mm disp in, (lot# p4m0877).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
It was reported that during a laparoscopic re-do rectopexy procedure, the device was fired, but the tacks failed, and a tack component fell into the cavity of the patient.It was noted that no x-ray was performed to locate or confirm retrieval of the tack.Two devices were tried without success, and the third device functioned as intended, allowing the procedure to be completed.
Additional Manufacturer Narrative
Correction: b1, b2, h1, h6.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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the timing was disrupted.Functional testing found that the trigger was jammed.The trigger was actuated after disassembling the body from the tube.Tacks were jammed in the tube and did not deploy due to the timing disruption.It was reported that the tack component fell.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue caused by an instrument that has been exposed to excessive force while applying helixes to a surface.If a helix is fired over improper surfaces, it can provoke the exertion of excessive force to the handle causing the unit to disrupt the timing and to a possible jam.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: do not use the instrument on tissue(s) which cannot be inspected visually for hemostasis.A minimum of 4 mm tissue thickness is required when applying the helical fastener over underlying bone, vessels, or viscera.Applying excessive pressure against the nose of the instrument may stall and/or jam the instrument.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: 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: 23001830
• Report Number: 2647580-2025-02735
• Device Sequence Number: 15661730
• Product Code: GCJ
• UDI-Device Identifier: 10884521070400
• UDI-Public: (01)10884521070400(17)291130(10)P4M0877
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Device Lot Number: P4M0877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 09/16/2025; 11/03/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 09/16/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown