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

Model Number	TA3035S
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during an open anterior resection, during stapling of the sigmoid colon, the stapler did not engage into firing position.A second stapler was used to resolve the issue.There was no patient injury.
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.
Additional Manufacturer Narrative
Additional information: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the instrument was received with a fully applied 3.5mm single use loading unit (sulu).Identifying witness mark from automatic firing fixture was present on instrument handle.Two malformed staples were stuck in two of the pusher finger slots.Both pusher fingers were damaged.Functionally, the two malformed staples were removed.The pushers on the sulu were reset and the sulu reloaded into the instrument.The jaw closes smoothly.The pin slide advances fully.The handle actuates smoothly into pre-clamped and clamped position.The jaw opens, handle unlocks, and pin slide retracts when black release button was depressed.The instrument and sulu were cycled 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 can occur if the device was applied over thick tissue exceeding the recommended tissue range.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: 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): 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: 18986600
• Report Number: 2647580-2024-01388
• Device Sequence Number: 2868408
• Product Code: GAG
• UDI-Device Identifier: 10884521043114
• UDI-Public: 10884521043114
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 05/02/2024

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: TA3035S
• Device Catalogue Number: TA3035S
• Device Lot Number: P3C0216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 05/02/2024
• 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