MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE

Model Number	SIGSDL45CTVT
Medical Device Problem Codes	Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946); Tissue Breakdown (2681)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a kidney transplant, after usage of the reload on the renal artery and vein, the surgeon released the kidney from the donor; unfortunately, there was massive bleeding from the artery at the staple line.The surgeon noticed that during clamping the artery and after pressing the green button to start firing, the artery was still moving between the jaws of the cartilage and not compressed properly between the jaws.The procedure was converted into an open surgery to control the bleeding, and hand sewing was done with the application of a hemoclip.Also, the procedure was extended by not less than six hours.It was also noted that the surgeon noticed the part of the artery had staples and at the corner of the artery it did not have staples, and this was the side of bleeding, and the stapling was intact at the specimen side.The patient was secured after controlling the bleeding but pushed for icu for close monitoring.
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.

• Brand Name: SIGNIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20295242
• Report Number: 1219930-2024-04462
• Device Sequence Number: 7209301
• Product Code: GDW
• UDI-Device Identifier: 10884521741843
• UDI-Public: 10884521741843
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K191070
• 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
• Report Date (Section B): 09/24/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: SIGSDL45CTVT
• Device Catalogue Number: SIGSDL45CTVT
• Device Lot Number: N2F0731UY
• 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: 09/09/2024
• Initial Report FDA Received Date: 09/24/2024
• Date Device Manufactured: 06/30/2022
• 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; Required Intervention
• Patient Sex: Male