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

Model Number	030454
Medical Device Problem Codes	Misfire (2532); Failure to Form Staple (2579); Firing Problem (4011)
Health Effect - Clinical Codes	Tissue Breakdown (2681); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: 030457 - endo gia r/or 60 2.5mm x6, lot# t2a158x.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 the procedure, one of the reload had staple line incomplete distally, the other reload had difficulty in firing.It was also mentioned that the jaw was unable to open after firing and had to open the jaw using another hand instruments.A new reload was used to resolve the issue and complete the case.
Event or Problem Description
According to the reporter, during the procedure, one of the reload had staple line incomplete distally, the other reload had difficulty in firing.It was also mentioned that the jaw of the second reload was unable to open after firing and had to open the jaw using another hand instruments.A new reload was used to resolve the issue and complete the case.
Additional Manufacturer Narrative
Correction: b5.Additional information: g3.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 the procedure, the first reload was fired for a half and near the last 15mm.With no proper staple line formation.It was mentioned that the jaw of the second reload got stuck and was unable to open in the middle of the firing.The jaw of the second reload had to be open using another hand instruments.A new reload was used to resolve the issue and complete the case.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (rfr, fdp, fdd, ime, imf).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: 20213355
• Report Number: 1219930-2024-04240
• Device Sequence Number: 7202616
• Product Code: GDW
• UDI-Device Identifier: 10884523002850
• UDI-Public: 10884523002850
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2024

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 Model Number: 030454
• Device Catalogue Number: 030454
• Device Lot Number: T2E073X
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 09/13/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 09/16/2024; 09/20/2024
• Date Device Manufactured: 05/05/2022
• 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.
• Patient Age: 24 YR
• Patient Sex: Male