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

Model Number	174006
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic, the user tried to fire it eight times, no staples came out.The other one, the staples seem to have simply fallen out.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant products 174006- 174006 protack 5mm disp in - lot# p5e1007.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: 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.A tack was protruding from the tip of the device.A visual inspection of the instrument revealed that the timing was disrupted, and the tack and spring were protruding from the tip of the device.The spring weld was acceptable.It was reported that no staples came out.The reported issue was not used as intended.The most likely cause could not be established from the information available.The malformed tacks or spring may occur when the timing is disrupted and the tack dose not disengage from the instrument and pulled from the tissue at the same time, stretching the tack and/or spring.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.This device should not be used in tissues that have a direct anatomic relationship to major vascular structures.This would include the deployment of helical fasteners in the diaphragm in the vicinity of the pericardium, aorta or inferior vena cava during diaphragmatic hernia repair.Do not use in ischemic or necrotic tissue.Replication of the timing condition is 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.Also (disengaged spring) states; do not apply excessive force when firing the instrument, as the instrument may jam.If a helical fastener becomes jammed, rotate the instrument counterclockwise.Applying e xcessive pressure against the nose of the instrument may stall and/or jam the instrument.To fire the instrument, simultaneously press the instrument nose against the tissue, mesh or patch and squeeze the handle completely; this sets the instrument for the next firing.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: 24355206
• Report Number: 2647580-2026-00391
• Device Sequence Number: 13233529
• Product Code: GCJ
• UDI-Device Identifier: 10884521070400
• UDI-Public: (01)10884521070400(17)300731(10)P5H1069
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 04/20/2026

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: P5H1069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• 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.
• Patient Sex: Female