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

Model Number	RELTACK3X10
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic hernia mesh implantation, the three reloads were difficult to load onto the articul ating tip of the handle.The devices were still able to be used on the patient.Three new reloads were used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant products: reltack3x10 reltack3x10 reliatack articulat reload a - (lot#n3k2220y); reltack3x10 reltack3x10 reliatack articulat reload a - (lot#n3k2220y); 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 disengaged for the instrument.Nine reloads were received.Inspection of the reloads noted that one reload was loaded in the yellow shipping tab with proper timing.Four reloads were received, loaded with the shipping tab with the timing disrupted.One reload was received with a broken shipping tab, the reload protruding out of the proximal end of the shipping tab, and the timing disrupted.Three reloads were received disengaged from the shipping tabs and fully fired.Functional testing found that the articulation knob functioned properly.The handle could be actuated and cycled properly with no reload attached.An rpa test reload could not be loaded due to the disrupted timing of the device.Rpa was unable to load the received reloads onto the returned instrument.A representative rpa instrument was used for the purposes of testing the reloads.The damaged reloads could not be loaded onto the test instrument.The intact reload could be loaded onto the test instrument.The instrument and reload were applied to the appropriate test media.All ten tacks were deployed and seated properly in the test media.It was reported that the device was diff icult to load.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur with excessive manipulation or improper loading and/or unloading of the sulu.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 attempt to remove the shipping wedge until the reload is locked and loaded onto the instrument.Ensure the device is in reload mode, the red toggle button is exposed, and the device is in the straight (unarticulated) position.To load the reliatack¿ device, select the appropriate reload, then pull and hold the blue lock switch button, located on top of the instrument, in the back position.Insert the pin located at the distal end of the shaft into the reload.Ensure that the arrow on the shaft is aligned with the arrow on the reload.Push the reload onto the distal end of the shaft until the two arrows meet.Release the lock switch button, allowing it to return to the forward position.Gently pull on the reload to confirm that the device is properly loaded.Remove the shipping wedge once the reload is properly locked and loaded.Instructions for unloading: push the left side of the toggle button to expose the red portion of the button and ensure that the device is in the straight (unarticulated) position.Pull and hold the blue lock switch button, located on top of the instrument, in the back position.Pull the reload off of the shaft of the device.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: RELIATACK
• 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: 24079441
• Report Number: 1219930-2026-00279
• Device Sequence Number: 13178198
• Product Code: GDW
• UDI-Device Identifier: 10884521202399
• UDI-Public: (01)10884521202399(17)280531(10)N5H1436Y
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K140609
• 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): 04/07/2026

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: RELTACK3X10
• Device Catalogue Number: RELTACK3X10
• Device Lot Number: N5H1436Y
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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