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

Model Number	SIGSDS30CTV
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant medical products: egiaustnd, egiaustnd endogia ultra univ std stap (lot#:p5a0819), egia30ctavm, egia30ctavm egia30 curved vas med sulu (lot#:n4l1516y), egia30ctavm, egia30ctavm egia30 curved vas med sulu (lot#:n4j1923y) 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
It was reported that during a surgical procedure using the egiaustnd endogia ultra univ std stap, the surgical time was extended by approximately 30 minutes due to bleeding or oozing observed along the staple lines after firing three vascular reloads to transect blood vessels.The surgeon noted varying degrees of bleeding along the staple lines, which ceased after switching to a different lot of the stapler.
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
It was reported that during a video-assisted thoracoscopic lobectomy surgery (vats), when using the endogia ultra univ std stap, the surgical time was extended by approximately 30 minutes due to bleeding or oozing observed along the staple lines after firing three vascular reloads to transect blood vessels.The surgeon noted varying degrees of bleeding along the staple lines, which ceased after switching to a different lot of the stapler.

• 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: 21760229
• Report Number: 1219930-2025-01537
• Device Sequence Number: 20955021
• Product Code: GDW
• UDI-Device Identifier: 10884521741874
• UDI-Public: 10884521741874
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Followup
• Report Date (Section B): 04/16/2025

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: SIGSDS30CTV
• Device Catalogue Number: SIGSDS30CTV
• Device Lot Number: N4D1961UY
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/16/2025
• Date Device Manufactured: 04/05/2024
• 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