MAUDE Adverse Event Report: US SURGICAL PUERTO RICO TA; STAPLER, SURGICAL

Model Number	TA6035S
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
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
According to the reporter during a bowel resection, the stapler failed to fire and when pressing the handle, the required clicks did not happen.Another stapler was opened and used with no issues.There was no patient injury.
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 loaded with a 3.5-millimeter (mm) single use loading unit (sulu) containing the full complement of staples.Identifying witness mark from automatic firing fixture was present on instrument handle.The upper portion of the trigger was broken.It was reported that the stapler failed to fire and when pressing the handle, the required clicks did not happen.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when attempting to fire with no loading unit, a previously fired loading unit or an improperly seated loading unit.This may also occur if the instrument jaws are clamped over an obstruction and fired.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: the instrument jaws will not close if a loading unit has not been loaded into the jaws, if the loading unit is not fully loaded into the jaws, or if a fired, or partially fired, loading unit is in the jaw.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): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 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: 22394242
• Report Number: 2647580-2025-02022
• Device Sequence Number: 18398200
• Product Code: GAG
• UDI-Device Identifier: 10884521043213
• UDI-Public: (01)10884521043213(17)291031(10)P4L0908(20)03
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: TA6035S
• Device Catalogue Number: TA6035S
• Device Lot Number: P4L0908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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
• Patient Sex: Unknown