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

Model Number	SIGSDS30CTV
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Tissue Breakdown (2681)
Date of Event	07/25/2024
Type of Reportable Event	Death
Event or Problem Description
According to the reporter, during a procedure to remove a right upper lobe due to lung cancer, the patient's saturation levels and pressure kept dropping.Patient was converted from a robotic surgery to an open surgery to gain more control for anesthesia to inflate the lungs.The surgeon fired a small-diameter reload (partially fired) on the pulmonary artery and had some oozing (there was blood loss).To control the bleeding, a blood transfusion and a cell saver were made.Suturing to repair the tear in the vessel would have been the resolution, but the patient could not get stable.The patient then began to crash further.A cardiac surgeon was called in, and resuscitation efforts commenced.The patient died.
Additional Manufacturer Narrative
D10 concomitant product: sigphandle, sig power sigphandle handle, (serial #unknown); unk-sigadapt, unknown signia egia adapter, (serial #unknown).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: 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 procedure to remove a right upper lobe due to lung cancer, the patient's saturation levels and pressure kept dropping.Patent was converted from a robotic surgery to an open surgery to gain more control for anesthesia to inflate the lungs.The surgeon fired a small-diameter reload (partially fired) on the pulmonary artery and had some oozing (there was blood loss).To control the bleeding, a blood transfusion and a cell saver were made.Suturing to repair the tear in the vessel would have been the resolution, but the patient could not get stable.The patient then began to crash further.A cardiac surgeon was called in, and resuscitation efforts commenced.The patient died due to cardiac arrest.

• 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: 19992827
• Report Number: 1219930-2024-03796
• Device Sequence Number: 8461035
• Product Code: GDW
• UDI-Device Identifier: 10884521741874
• UDI-Public: 10884521741874
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: SIGSDS30CTV
• Device Catalogue Number: SIGSDS30CTV
• Device Lot Number: N4B1839UY
• 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: 07/25/2024
• Supplement Date Received by Manufacturer: 08/11/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 08/26/2024
• Date Device Manufactured: 02/10/2024
• 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: Required Intervention; Death
• Patient Age: 79 YR
• Patient Sex: Female