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

Model Number	TA3048S
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
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 the procedure the stapler did not fire despite full, complete squeezes of the handle.The device was replaced to resolve the issue.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 it was received loaded with a single use loading unit (sulu) displaying the full complement of staples.The sulu was received improperly loaded.The thumb button was advanced.Identifying witness mark from automatic firing fixture was present on instrument handle.The sulu was removed; the thumb button was pulled back to the neutral position and the sulu was reloaded into the instrument.The jaw closed smoothly.The pin slide advanced fully.The handle actuated smoothly into pre-clamped and clamped positions.The jaw opened, handle unlocked and pin slide retracted when black release button was depressed.The instrument and sulu were fired over test media with acceptable staple formation.The handle was cycled a second time after the black release button was depressed to challenge the interlock with acceptable results.It was reported that the instrument did not fire.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The issue may occur if the sulu was loaded with the pin slide and thumb buttons advanced.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: to reload the instrument, grasp the new, unused loading unit by the finger pads, with the staple holes facing the instrument anvil.Insert the loading unit into the metal cartridge housing and push firmly downward until the single use loading unit clicks into position.The instrument jaws will not close if a sulu is not loaded in the jaws, if the sulu is not fully loaded into the jaws, or if a fired, or partially fired, sulu 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22126510
• Report Number: 2647580-2025-01685
• Device Sequence Number: 12931229
• Product Code: GAG
• UDI-Device Identifier: 10884521043138
• UDI-Public: 10884521043138
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 07/28/2025

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: TA3048S
• Device Catalogue Number: TA3048S
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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