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

Model Number EEAXL28

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Failure to Anastomose (1028); Tissue Breakdown (2681); Insufficient Information (4580)

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

D10 concomitant product: eeaxl2835, eeaxl2835 eea xl28 mm-3.5 sgl use stap (lot#p3b0273).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 open colosotomy reversal, when creating the anastomosis of the colon, the surgeon squeezed the device once to fire the device.Afterwards, when the surgeon decided to do a second squeeze, there was a loud crack and the top of the tilt top anvil broke off and fell into the patient's cavity and was retrieved by the surgeon from the anal cavity by hand.It was also reported that the anastomosis had a leak.Another stapler was used and it had the same issue.

Event Description

According to the reporter, during a open colosotomy reversal, when creating the anastomosis of the colon, the surgeon squeezed the device once to fire the device.Afterwards, when the surgeon decided to do a second squeeze, there was a loud crack and the top of the tilt top anvil broke off and fell into the patient's cavity and was retrieved by the surgeon from the anal cavity by hand.It was also reported that the anastomosis had a leak.

Manufacturer Narrative

Additional information: b5, g3, h6 new information has been received pertaining to the event (device is an unauthorized return base on the e-mail provided by sales rep.) this event has been reassessed and found not to be a reportable event and is not associated with a serious injury or potential for serious injury with reoccurrence.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.

Manufacturer Narrative

Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.A comprehensive e xamination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.No information regarding the specific customer issue that occurred with the device was available.Upon examination of the sample, it was found that there was a disengaged anvil head.Visual inspection of the staple guide noted the instrument was fully applied.Further inspection noted that the green bar was not visible in the indicator window and the safety feature was not engaged.The staple guide was observed to be attached to the instrument with no damage to the staple guide.After actuating the handle, the pusher fingers appeared to be intact and inspection under the microscope displayed damage to the knife blade.The anvil head was disengaged from the center rod and the center rod was attached to the instrument.Further inspection of the anvil cutting ring showed deep traces of knife impression and the ring was received completely severed.The product analysis noted evidence that the device was not used as intended.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: make certain that the section of tissue to be stapled is free from any metal clips or similar structures; otherwise, the knife blade may not cut.The tilt-top¿ anvil cannot be detached from the anvil/center rod assembly.This device is provided sterile and is intended for use in a single procedure only.Discard after use and do not sterilize.Do not try moving the stapler at the same time as opening it.Doing so may result in the anvil catching on the anastomotic lip as it will not have fully tilted, which could cause difficulty in removing the stapler from the patient.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 open colosotomy reversal, when creating the anastomosis of the colon, the surgeon squeezed the device once to fire the device.Afterwards, when the surgeon decided to do a second squeeze, there was a loud crack and the top of the tilt top anvil broke off and fell into the patient's cavity and was retrieved by the surgeon from the anal cavity by hand.It was also reported that the anastomosis had a leak.Device returned without accompanying information.

• 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: 19033273
• MDR Text Key: 339256501
• Report Number: 2647580-2024-01475
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 10884523006131
• UDI-Public: 10884523006131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

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
• Device Operator: Health Professional
• Device Model Number: EEAXL28
• Device Catalogue Number: EEAXL28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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: PLEASE SEE NOTE ON H11
• Patient Sex: Male