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

Model Number	030456
Medical Device Problem Codes	Misfire (2532); Failure to Form Staple (2579); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Laceration(s) (1946); Tissue Breakdown (2681)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: 030459, 030459 endo gia r/or 60 4.8mm, (lot #t2j045x) egiauxl, egiauxl endogia ultra univ xl stapler, (lot #p2f0346) 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, in a laparoscopic chest wall resection and reconstruction, during chest wall tumor resection, with two reloads, the surgeon was able to press the green button and squeeze the handle but there was poor staple formation and incomplete staple line.The blade was not moving forward and stopped after the first squeeze.The pins were not fixed and the staple line was incomplete centrally.The procedure was converted to open due to the issue.The pins of the reload fell into cavity and removed with a grasper.The surgeon then used an open stapler instead of a laparoscopic stapler.The surgical time was extended for about 10 to 15 minutes due to the procedure¿s conversion to open.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the loading unit was partially fired and the anvil was bowed.The clamping mechanism was deformed.It was reported that there was partial firing and an issue with staple formation.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the 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.It was also reported that there was component disengaged and the staple line incomplete.The reported issues 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.The instructions included with this device provide the following guidance: select a loading unit with the appropriate staple size for the tissue thickness.Overly thick or thin tissue may result in unacceptable staple formation.Always include the combined thickness of the tissue and of any staple line reinforcement material in use when choosing the proper staple cartridge.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: 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: 19356469
• Report Number: 1219930-2024-02224
• Device Sequence Number: 6500589
• Product Code: GDW
• UDI-Device Identifier: 10884523002874
• UDI-Public: 10884523002874
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111825
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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 Expiration Date: 02/19/2026
• Device Model Number: 030456
• Device Catalogue Number: 030456
• Device Lot Number: T1B337X
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2021
• 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
• Patient Sex: Unknown