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

Model Number	SIGSDL45CTVT
Medical Device Problem Code	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	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during the total nephrectomy, there was no bleeding at the time of implantation on the renal artery and renal vein.Following that, the surgeon reported that the artery which had been occluded with the stapler, was bleeding profusely.The patient required intubation, had a blood loss of more than 500cc, the incision was extended for more than one inch, and was admitted to the intensive care unit.The patient was currently has been extubated and is in good condition.
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.
Additional Manufacturer Narrative
Additional information: b3, 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.A video was also provided.Visual inspection noted that there was a loosed formed staples in the tissue cavity.There was an adapter connected to the handle and shell, and another two adapters with three reloads on the table.The jaws of the reload could not be properly examined and there was no bleeding from the staple line.It was reported that there was a staple line bleeding.The reported issue could not be confirmed.The most likely cause could not be established from the information available.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: 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: 19585585
• Report Number: 1219930-2024-02754
• Device Sequence Number: 19715289
• Product Code: GDW
• UDI-Device Identifier: 10884521741843
• UDI-Public: 10884521741843
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K191070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/06/2024

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: SIGSDL45CTVT
• Device Catalogue Number: SIGSDL45CTVT
• Device Lot Number: N3L2090UY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 08/21/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 06/26/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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; Other
• Patient Sex: Male