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

Model Number	EGIA45AV
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Firing Problem (4011)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: egiaushort, egiaushort endogia ultra univ sht stap, 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 an open right liver lobectomy, when the hepatic vein was resected, the device was difficult to fire but it was able to be fired.The device was detached from the resected blood vessel after stapling, there was an excessive hemorrhaging during left hepatic lobectomy when the middle and left roots of the hepatic vein were treated all at once.Blood vessel wall ruptured to the area near inferior vena cava, and a cardiovascular surgeon performed vascular reconstruction using an artificial heart lung.Manual suturing was also performed.The cardiac arrest time was 20 minutes.Surgical time was extended.Currently, the patient¿s condition is stable.
Additional Manufacturer Narrative
Additional information: g3, h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.A video was also provided.Visual inspection noted that the reload was fully fired with the interlock engaged.The jaws were open.A visual inspection of the returned video and photos noted, the handle was actuated but the tissue was unable to be cut.Blood could be seen pooling under the held tissue.The reload appeared difficult to fire.Two images of resected tissue and one image of loose staples could be seen.A partially formed staple could be seen inside of the tissue.Several of the loose staples appeared malformed and damaged.The remaining staples were partially formed.It was reported that the staple line was bleeding and the device was difficult to fire.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.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.
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 an open right liver lobectomy, when the hepatic vein was resected, the device was difficult to fire but it was able to be fired.The device was detached from the resected blood vessel after stapling, there was an excessive hemorrhaging during left hepatic lobectomy when the middle and left roots of the hepatic vein were treated all at once.Blood vessel wall ruptured to the area near inferior vena cava, and a cardiovascular surgeon performed vascular reconstruction using an artificial heart lung.Manual suturing was also performed.The cardiac arrest time was 20 minutes.Surgical time was extended by four hours and 42 minutes.Currently, the patient¿s condition is stable.

• Brand Name: ENDO GIA
• 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: 20482035
• Report Number: 1219930-2024-04968
• Device Sequence Number: 8405978
• Product Code: GDW
• UDI-Device Identifier: 10884523003161
• UDI-Public: 10884523003161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111825
• 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,Followup
• Report Date (Section B): 01/20/2025

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: EGIA45AV
• Device Catalogue Number: EGIA45AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 11/12/2024; 01/16/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/19/2024; 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown