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

Model Number	EEA2535
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Product Quality Problem (1506); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic gastric bypass procedure, while performing the anastomosis pouch with the intestine, the anvil legs bent, making it difficult or impossible to close.The tilt-top anvil disconnected from the trocar during the stapler closure.It was noticed that the tilt-top anvil was larger than the same size in another stapler.A new circular stapler was used to resolve the issue.
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.

• 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: 19391407
• Report Number: 2647580-2024-02250
• Device Sequence Number: 7049759
• Product Code: GAG
• UDI-Device Identifier: 10884523004748
• UDI-Public: 10884523004748
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Report Date (Section B): 05/24/2024

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: EEA2535
• Device Catalogue Number: EEA2535
• Device Lot Number: P2K0390
• 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: 04/26/2024
• Initial Report FDA Received Date: 05/24/2024
• Date Device Manufactured: 10/21/2022
• 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
• Patient Sex: Female