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

Model Number	TRIEEA33XT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Post Operative Wound Infection (2446); Unintended Radiation Exposure (4565)
Date of Event	09/23/2024
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 primary anastomosis procedure, there was no issue with the device.The proximal and distal donuts were inspected and appeared completed.Two days later, when completing the ward round, there were feces in the drain.The patient was taken back to the theater.The surgeon completed three leak tests during this, and no air bubbles or leak points were identified.However, there was a small amount of feces in the abdomen on the retractor.The anastomosis was taken down, and a colostomy was done.Follow-up computed tomography (ct) scan showed no identifiable pelvic collection but has a wound infection.A negative pressure wound therapy system dressing was applied.The patient was fine and is recovering.
Additional Manufacturer Narrative
Additional information: b5, g3 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 primary anastomosis procedure, there was no issue with the device.The proximal and distal donuts were inspected and appeared completed.Two days later, when completing the ward round, there were feces in the drain.The patient was taken back to the theater.The surgeon completed three leak tests during this, and no air bubbles or leak points were identified.However, there was a small amount of feces in the abdomen on the retractor.The anastomosis was taken down, and a temporary colostomy was done.Follow-up computed tomography (ct) scan showed no identifiable pelvic collection but has a wound infection.A negative pressure wound therapy system dressing was applied.The patient was fine and is recovering.

• Brand Name: EEA
• 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: 20471202
• Report Number: 2647580-2024-04449
• Device Sequence Number: 7353260
• Product Code: GAG
• UDI-Device Identifier: 10884521593077
• UDI-Public: 10884521593077
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172361
• 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): 10/22/2024

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: TRIEEA33XT
• Device Catalogue Number: TRIEEA33XT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 10/22/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male