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

Model Number EEA28

Device Problems Misfire (2532); Failure to Form Staple (2579); Mechanics Altered (2984); Noise, Audible (3273)

Patient Problem Tissue Breakdown (2681)

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: eea28 eea 28mm-4.8 sgl use stapler (lot#: p3h1144); eea28 eea 28mm-4.8 sgl use stapler (lot#: p3h1144) 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 laparoscopic ivor lewis oesophagectomy procedure, at the time of end to end anastomosis of the o esophagus, the staples were unformed and there was no donut.It was also noted that the device did not make the clicking sound when the anvil and handle was connected and the handle did not feel normal when it was squeezed.The surgeon then removed the staples and used a second stapler.However the same issue occurred.A third handle was used to resolve the issue.This led to around 30-45mins extended surgical time.It was noted that the surgeon was unable to observe the orange band or its disappearance while connecting the anvil to the handle due to the tight space the surgeon was working in was working in.It was also noted that the procedure was converted into an open thoracotomy procedure; the conversion was not due to the device 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: 19047935
• MDR Text Key: 339590369
• Report Number: 2647580-2024-01499
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 10884523005530
• UDI-Public: 10884523005530
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EEA28
• Device Catalogue Number: EEA28
• Device Lot Number: P3H1144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2023
• 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
• Treatment: SEE NOTE ON H11
• Patient Age: 54 YR
• Patient Sex: Female