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

Model Number	030415
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 mediastinal tumor resection, before cutting the mediastinum tissue, the nurse connected the reload and held the grip tightly, but the jaws did not close.To resolve the issue, a new reload and handle were used.There was no patient injury.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the loading unit had a full staple complement.The anvil clamping mechanism was deformed.The tissue stops on both the right and left side of the loading unit were peeled back towards the distal end.It was reported that the jaws would not close.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The deformed clamping mechanism may occur through manipulation of tissue using the anvil side of the loading unit, or clamping over excessive thickness.The tissue stop deformation may occur when the tissue stop catches on the trocar during removal, or if an attempt is made to remove the device while in the articulated position.Any forceful effort to remove the loading unit will result in the tissue stop being peeled distally and prevent the loading unit from being removed from the trocar.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.Placement of tissue proximal to the tissue stops (on the loading unit) may result in stapler malfunction.Any tissue extending beyond the cut mark will not be transected.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: 20729739
• Report Number: 2647580-2024-04869
• Device Sequence Number: 18218937
• Product Code: GDW
• UDI-Device Identifier: 10884523002935
• UDI-Public: 10884523002935
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 01/30/2025

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: 030415
• Device Catalogue Number: 030415
• Device Lot Number: P1L0551S
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 61 KG