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

Model Number	ABSTACK30X
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); 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	02/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, intra-operatively of a laparoscopic umbilical hernia repair, during mesh fixation, a tacker with 30 tacks was used initially.After the tacker was inserted into the trocar, the shaft of the trocar got bent and broken.The surgeon could not remove the tacker from the trocar.The surgeon could not fire any tacks properly.Tacks fell into the cavity of the patient and were retrieved.A tacker with 15 tacks was used afterwards.However, after four tacks, the trigger of the tacker got hard and did not function properly.Tacks also fell into the cavity of the patient and were retrieved.Suturing was done instead to fix the mesh.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant product: abstack15, abstack15 abs fixation device 15 tacks, (lot # n5k1784y) 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: 24566924
• Report Number: 1219930-2026-01582
• Device Sequence Number: 9507246
• Product Code: GDW
• UDI-Device Identifier: 10884521184213
• UDI-Public: (01)10884521184213(17)280531(10)N5F1921Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123109
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 03/11/2026

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: ABSTACK30X
• Device Catalogue Number: ABSTACK30X
• Device Lot Number: N5F1921Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2026
• Initial Report FDA Received Date: 03/11/2026
• Date Device Manufactured: 06/18/2025
• 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: Unknown