MAUDE Adverse Event Report: COVIDIEN TA; STAPLER, SURGICAL

Model Number	TA9048S
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intraoperatively, a small bowel fistula due to an incisional hernia plaque via laparotomy.To perform the anastomosis, the surgeon first created a lateral anastomosis of the small bowel using a gia stapler, then a lateral anastomosis using a ta stapler.The initial ta stapler did not fire, no staples were delivered.A second ta stapler was retrieved.This time, the stapler was closed on the small bowel, but only a few staples were placed, and the incision was not completely closed.The anastomosis was not performed under the most aseptic conditions possible.There was injury to the edges of the anastomosis, a cut in the small bowel, and consequent shortening of the anastomosis.Two additional staplers from another company were used to complete the procedure successfully.
Additional Manufacturer Narrative
D10 concomitant product: ta9048s, ta9048s ta 90-4.8 reloadable stapler (lot # p5e0795) 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: 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 4.8¿mm single use loading unit (sulu).Examination of the sulu revealed that several staples were partially advanced within the cartridge and remained in an unformed condition.The pusher slots that did not contain partially advanced staples were found to be empty.The identifying witness mark from the automatic firing fixture was also present on the instrument handle.It was reported that the staple line was incomplete.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the firing stroke is not completed during application.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 fire the instrument, squeeze the handle a second time until it reaches a solid stop and it locks in the back position.If the ins trument handle is partially squeezed during firing then released, bleeding may occur as the instrument was not fully fired.The black release button may be used to open the instrument at any time during approximation.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: 24057791
• Report Number: 2647580-2026-00090
• Device Sequence Number: 13117089
• Product Code: GAG
• UDI-Device Identifier: 10884521043275
• UDI-Public: (01)10884521043275(17)290831(10)P4J0779(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/20/2026

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: TA9048S
• Device Catalogue Number: TA9048S
• Device Lot Number: P4J0779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown