MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIG45CTAV
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: sigphandle, sig power sigphandle handle (serial#: unknown); sigpshell, sig power sigpshell control shell (lot#: unknown); sigadaptshort, sig power sigadaptshort lin short adapt (serial#: unknown); unknown endo gia sulu (lot#: 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.
Event or Problem Description
According to the reporter, during right lower pulmonary vein resection for thoracoscopic right lower lobectomy, the right side (erasion side) in the direction of staple progression was successfully stapled, but the left side (central side) was not stapled, leading to cut-end bleeding.There was 2000 cc of blood loss from the cut end, the heart rate dropped to 30, and we almost had a cardiac arrest.The incision was widened from 4 cm to 20 cm, and the bleeding was stopped with a finger.A cardiovascular surgeon performed the sutures.After that, a cardiovascular surgeon then enters the operating room (op), clamps the cut end with forceps, and ligates it.After completing the operation, the patient was transferred to the intensive care unit (icu) and was currently recovering.Hospitalization was extended.The patient recovered safely and has been discharged from the hospital.
Event or Problem Description
According to the reporter, during right lower pulmonary vein resection for thoracoscopic right lower lobectomy, the right side (erasion side) in the direction of staple progression was successfully stapled, but the left side (central side) was not stapled, leading to cut-end bleeding (the inferior pulmonary vein was cut just barely on the side of the heart and it was intended by the surgeon).There was 2000 cc of blood loss from the cut end, the heart rate dropped to 30.The incision was widened from 4 cm to 20 cm, and the bleeding was stopped with a finger.A cardiovascular surgeon performed the sutures.After that, a cardiovascular surgeon then enters the operating room (op), clamps the cut end with forceps, and ligates it.After completing the operation, the patient was transferred to the icu and is currently recovering.Hospitalization was extended.The patient recovered safely and has been discharged from the hospital.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the interlock was overridden and the reload was cycled without hesitation or binding.The reload interlock was tested and found to function properly.It was reported that the staple line was incomplete.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur under the following conditions, application over tissue that is beyond the recommended thickness range.Application with an obstacle incorporated in the jaws.In any of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract.In addition, staples may not form properly and tissue may not be fully transected.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: always inspect the tissue thickness and select an appropriate staple size prior to application of the endo gia¿ ultra universal short, endo gia¿ ultra universal or endo gia¿ ultra universal xl stapler.Overly thick or thin tissue may result in unacceptable staple formation.When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.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: TRI-STAPLE 2.0
• 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: 19735682
• Report Number: 1219930-2024-03188
• Device Sequence Number: 12514018
• Product Code: GDW
• UDI-Device Identifier: 10884521543706
• UDI-Public: 10884521543706
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160176
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIG45CTAV
• Device Catalogue Number: SIG45CTAV
• Device Lot Number: N4B1747Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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 NOTE ON H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown