MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA; STAPLER, SURGICAL

Model Number	EEAXL25
Medical Device Problem Codes	Break (1069); Failure to Form Staple (2579); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949); Noise, Audible (3273)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Breakdown (2681)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during an ivor lewis esophagectomy procedure, when performing the anastomosis, the surgeon was squeezing the handle stating that the safety was not letting go.The surgeon kept squeezing, a snap was heard and the safety lever broke.All pieces of the lever was found.The surgeon kept using the stapler, when the handle was squeezed, the usual crunch sound was not heard.When the stapler was pulled the anvil was still attached, and the tissue rings were intact, but the ring part of the stapler was missing.Further dissection was required to do another anastomosis, and while doing it, they found inside the patient a full ring of staples loose as the staples did not form properly and the ring part of the stapler where it attaches to the anvil.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but three photos were available for evaluation.Visual inspection noted the safety and staple guide are disengaged and the staple guide appears to have a full complement of staples.It was reported that a component disengaged, handle broken, instrument made strange noise, no audible feedback, and staple formation.The reported issues were confirmed.The most likely cause could not be established from the information available.This issue may occur if the latch is forced into disengagement prior to green indicator visibility.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: the safety will not release if the green bar is not visible in the indicator window.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: EEA
• Common Device Name: STAPLER, SURGICAL
• 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: 19088460
• Report Number: 2647580-2024-01583
• Device Sequence Number: 18032102
• Product Code: GAG
• UDI-Device Identifier: 10884523006056
• UDI-Public: 10884523006056
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221003
• 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
• Report Date (Section B): 06/19/2024

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: EEAXL25
• Device Catalogue Number: EEAXL25
• Device Lot Number: P3D0164
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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 Sex: Unknown