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

Model Number	030453
Medical Device Problem Codes	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/30/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter during an open abdominal surgery (laparotomy, hepatic left lobe resection), it was confirmed that the anvil of the reload curved towards the tip.A few seconds after the firing was performed and released, there was bleeding from the central side, and the staple formation status of the staple line could not be checked.On left hepatic lobectomy, lymph node resection was performed and the left hepatic vein was resected at the root, and the anvil of the reload was approached to the blood vessel perpendicularly with the dorsal side, so it was approached by articulating about 2 articulations to the right so that the blood vessel was inside of the cartridge cutline, and firing was performed.It was said that the firing resistance was the same as usual.Also, the thickness of the blood vessel and tissue fragility were not particularly thick or fragile.Cardiac arrest occurred during the operation.To resolve the issue, the cardiovascular surgery physician also added a median sternotomy to block the ivc from the intrathoracic cavity and reconstruct the ivc.The damaged left hepatic vein was sutured afterwards.After suturing the left hepatic vein, the wound was closed and the patient was transferred to icu without left hepatectomy finishing.Subsequently, the patient died after.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the device was applied on over indicated tissue.The instrument's clamping mechanism was deformed, and the anvil was bowed.It was reported that an unexpected bleeding occurred along the staple line and the device had bent out of its intended shape.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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12482800
• Report Number: 1219930-2021-03859
• Device Sequence Number: 19767288
• Product Code: GDW
• UDI-Device Identifier: 10884523002843
• UDI-Public: 10884523002843
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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 Expiration Date: 02/28/2023
• Device Model Number: 030453
• Device Catalogue Number: 030453
• Device Lot Number: N8C0617KRX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2018
• 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: Death
• Patient Age: 75 YR
• Patient Sex: Male