MAUDE Adverse Event Report: COVIDIEN TA; STAPLER, SURGICAL

Model Number	TA30V3S
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that during a laparoscopic lung resection procedure, the stapler exhibited poor staple formation while detaching tissue.Additional suturing of the incision and over sewing of the staple line were performed to address the staple line issue.
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 instrument was received with a fully applied 2.5mm single use loading unit (sulu).Identifying witness mark from automatic firing fixture was present on instrument handle.A malformed staple was stuck in one of the pusher finger slots.The pusher finger from this slot was damaged.Functional testing noted that the malformed staple was removed.The pushers on the sulu were reset and the sulu reloaded into the instrument.The jaw closed smoothly.The pin slide advanced fully.The handle actuated smoothly into pre-clamped and clamped position.The jaw opened, handle unlocked, and pin slide retracted when black release button was depressed.The instrument and sulu were cycled with acceptable results.It was reported that there was issue with staple formation.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The issue may occur if the device was applied over thick tissue exceeding the recommended tissue range.The manufacturing records for each device are thoroughly r eviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: tissue thickness should be carefully evaluated before firing any stapler.Refer to specification chart and the tissue compression re quirement section.Tissue compression requirement refers to the compression requirement of each staple size.The ta loading units should not be used on tissue that will not comfortably compress, or that compresses to less than, the specified compression requirements, displacement may occur, and or hemostasis may not be obtained.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: TA
• Common Device Name: STAPLER, SURGICAL
• 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: 22894360
• Report Number: 2647580-2025-02598
• Device Sequence Number: 20312378
• Product Code: GAG
• UDI-Device Identifier: 10884521043145
• UDI-Public: (01)10884521043145(17)271130(10)P2M0461S(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K231491
• 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): 10/24/2025

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: TA30V3S
• Device Catalogue Number: TA30V3S
• Device Lot Number: P2M0461S
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 80 KG