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

Model Number	EGIATRS45AMT
Medical Device Problem Codes	Material Rupture (1546); Failure to Form Staple (2579)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant product: sigtrsb45amt 45mm med thk reinforced rel (lot#: n2m0301y) 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, in a laparoscopic bariatric procedure, when firing the stapler in the stomach, the reinforcement sheet of two reloads tore during stapling.There was poor staple formation.It was necessary to use additional reloads to resolve the poor staple formation.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 correction: e1 (fax number) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that there were four images of staple lines.The staples appeared to have properly formed.Two pieces of torn reinforcement material could be seen outside of the tissue cavity.It was reported that there was poor staple formation.The reported issue 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.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: 19312460
• Report Number: 1219930-2024-02086
• Device Sequence Number: 15157647
• Product Code: GDW
• UDI-Device Identifier: 10884521190887
• UDI-Public: 10884521190887
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K133938
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: EGIATRS45AMT
• Device Catalogue Number: EGIATRS45AMT
• Device Lot Number: N1H0431Y
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTE ON H11
• Patient Sex: Male