MAUDE Adverse Event Report: COVIDIEN SURGICAL ABSORBATACK; STAPLE, IMPLANTABLE

Model Number	ABSTACK15
Medical Device Problem Codes	Failure to Advance (2524); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic ventral hernia (ipom) procedure with mesh fixation, the first tacker the firing mechanism repeatedly got stuck, and during attempted fixation, tearing of the mesh occurred.Additionally, 4¿5 tacks came out from the shaft without getting fixed into the tissue.A second tacker was opened, but similar problems were observed, including the handle getting locked multiple times and the surgeon being able to fire only 7¿8 tacks out of 15.These issues led to procedural difficulty and dissatisfaction during mesh fixation.Intracorporeal suturing was performed to resolve the issue and complete the case.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
D10 - concomitant product: abstack15, abstack15 abs fixation device 15 tacks, (lot# n5f1683y).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 visual inspection of the product noted one instrument returned without the blister pack.No abnormalities were observed upon inspection of the tube assembly.The device was received fully fired.The handle was actuated, the instrument cycled and a clicking noise was noted on trigger/ handle reset.It was reported that the firing mechanism repeatedly got stuck, and during attempted fixation, tearing of the mesh occurred the reported issue was 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.

• Brand Name: ABSORBATACK
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 24096148
• Report Number: 1219930-2026-00320
• Device Sequence Number: 18720126
• Product Code: GDW
• UDI-Device Identifier: 10884523006506
• UDI-Public: (01)10884523006506(17)280531(10)N5F1683Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K071920
• 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): 03/26/2026

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: ABSTACK15
• Device Catalogue Number: ABSTACK15
• Device Lot Number: N5F1683Y
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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: Male