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

Model Number EEA31

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Tissue Breakdown (2681)

Event Type  malfunction  

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 Description

According to the reporter, during a sigmoidectomy, there was difficulty removing the stapler from the cavity.The anastomosis was teared when the stapler was removed.There was tissue damage due to the issue.A leak was visible when air was introduced and bubbles came out.The anastomosis was manually sutured to resolve the issue.

• Brand Name: EEA
• Type of Device: 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: 18979528
• MDR Text Key: 338614650
• Report Number: 2647580-2024-01381
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 10884523005554
• UDI-Public: 10884523005554
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K221003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EEA31
• Device Catalogue Number: EEA31
• Device Lot Number: P3A0057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Date Device Manufactured: 01/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 75 KG