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

Model Number	EEAXL2535
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Break (1069); Detachment of Device or Device Component (2907); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a gastric resection, the anvil was placed trans-orally successfully.However, surgical team was not able to mate the stapler with the oral anvil.The user were not able to apply the force needed to completely mate the two items.The surgeon made the decision to remove the oral anvil trans-orally and start fresh with a new oral anvil.While the surgeon was removing the anvil using the "advancing proximal guide suture", the suture broke free of the anvil, leaving the anvil lodged in the patient's esophagus.The surgeon used an endoscope and snare to lasso the anvil and finally remove it from the patient.The surgical time was extended for over an hour. the new oral anvil and circular stapler worked and the anastomosis was competed with success.
Additional Manufacturer Narrative
D10 concomitant products: eeaorvil25a, eeaorvil25a eea orvil 25mm automaticdv (lot#:n3e0275y) 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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the orvil anvil was difficult to attach and disengaged.The suture was broken.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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: 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 n; e; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19735776
• Report Number: 2647580-2024-03074
• Device Sequence Number: 12514023
• Product Code: GAG
• UDI-Device Identifier: 10884523006124
• UDI-Public: 10884523006124
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2024

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 Model Number: EEAXL2535
• Device Catalogue Number: EEAXL2535
• Device Lot Number: P2L0074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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
• Patient Sex: Unknown