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

Model Number	TA3035S
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	09/30/2024
Type of Reportable Event	Serious 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.
Event or Problem Description
According to the reporter, during a procedure, the stapler failed to deploy which resulted in a coloanal anastomosis as opposed to a stoked ultra low.Suturing as a staple line replacement was done to resolve the issue.It was noted that the patient was hospitalized and an additional surgery was done.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.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 stapled ultra low anterior resection, the surgeon completed the first full squeeze of the handle and it returned to open position ready for the second squeeze.The user noted that the first squeeze felt normal.The doctor then completed the second squeeze to deploy the staples however the second squeeze felt different and did not have the same force as the first.The staples failed to deploy which resulted in a coloanal anastomosis as opposed to a stoked ultra low.The anastomosis was performed at the same area of tissue so there was no unanticipated tissue loss.Suturing as a staple line replacement was done to resolve the issue.It was noted that the patient was hospitalized slightly longer than expected and an additional surgery was done.It was also noted that 40 minutes was added to the procedure as a result of the incident.
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.Functional testing found that the jaw closed smoothly, the pin slide advanced fully, and 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.Acceptable staple formation was observed on test media.It was reported that the staples did not deploy.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 excessive bodily fluids built up inside and around the sulu preventing proper function of the instrument causing an obstruction.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: 20461782
• Report Number: 2647580-2024-04438
• Device Sequence Number: 12969421
• Product Code: GAG
• UDI-Device Identifier: 10884521043114
• UDI-Public: 10884521043114
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 12/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TA3035S
• Device Catalogue Number: TA3035S
• Device Lot Number: P3J1021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 12/05/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 10/22/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown