MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ABSORBATACK; STAPLE, IMPLANTABLE

Model Number	ABSTACK30X
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Prolapse (2475); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during laparoscopic bilateral inguinal hernia repair the tacker was being applied to muscle and coopers ligament to secure the mesh.While using the device the tacker misfired and it was noted that the tacks fell into the patient's cavity and was retrieved using laparoscopic grasper.Another tacker was opened of the same lot and was found to have the same issue.To complete the procedure another tacker was opened and used without an issue.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant product: abstack30x, abstack30x abs fixation device30 tacks (lot#n4k1912y).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: b2, b5, d9, h1, h6.Correction: a3.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, during laparoscopic bilateral inguinal hernia repair the tacker was being applied to muscle and coopers ligament to secure the mesh.While using the device the tacker misfired and it was noted that the tacks fell into the patient's cavity and was retrieved using laparoscopic grasper.Another tacker was opened of the same lot and was found to have the same issue.To complete the procedure another tacker was opened and used without an issue.The patient was later readmitted for a follow-up, likely due to the misfiring tacker not adequately securing the mesh on the left side.A bulge had developed, which was corrected through an open procedure with a suture to reinforce the weakened area.During the procedure, it was noted that the mesh was wrinkled, indicating improper fixation from incomplete tack firing.
Additional Manufacturer Narrative
H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the tacks did not hold.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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: with the distal end of the shaft perpendicular to the area to be fixated, squeeze the trigger fully.The trigger should be squeezed to the full extent of it's travel, and held in the fully squeezed position as the device is moved off the application site.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 LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21358771
• Report Number: 1219930-2025-00696
• Device Sequence Number: 12882210
• Product Code: GDW
• UDI-Device Identifier: 10884521184213
• UDI-Public: 10884521184213
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123109
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2025

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: N4K1912Y
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/27/2025; 04/01/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/07/2025; 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female