MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030419
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: egiauxl, egiauxl endogia ultra univ xl stapler (lot#p2h0242); egiauxl, egiauxl endogia ultra univ xl stapler (lot#p3c0336) 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 a laparoscopic appendectomy, after loading the reload, the handle was squeezed, but the jaws did not close and released correctly.A new reload was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the jaws were open.Functional testing found that the jaws clamped and unclamped repeatedly without difficulty.It was reported that the jaws would not close.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: of a pre-fired loading unit.Visual examination noted that the loading unit was pre-fired with the interlock engaged.There were staples protruding from proximal staple cartridge channel.Functional testing found that the loading unit was loaded into a representative instrument.The interlock was overridden and the loading unit was applied to the test media.All staples were placed and the test media was cleanly transected.The loading unit interlock was tested and found to function properly.The product analysis noted evidence that the device was not used as intended.This issue can occur if the instrument firing handle had been partially com-pressed and released after pressing the green firing button.In this situation, the safety interlock feature will engage and prevent the reload from firing a second time.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: in order to fire the instrument, push the green button.Squeeze the handle sequentially until the oval clamp cover reaches the distal end of the cartridge slot, and the handle locks.Sequential squeezes of the handle are required to fully fire the loading unit.The total number of squeezes is relative to the length of the loading unit (30, 45 or 60).Failure to completely fire the loading unit will result in an incomplete cut and/or incomplete sta-ple formation, which may result in poor hemostasis.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): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19075351
• Report Number: 2647580-2024-01547
• Device Sequence Number: 4658524
• Product Code: GDW
• UDI-Device Identifier: 10884523002966
• UDI-Public: 10884523002966
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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: 030419
• Device Catalogue Number: 030419
• Device Lot Number: P2A0462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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: PLEASE SEE NOTE ON H11
• Patient Sex: Unknown