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

Model Number EEAXL2835

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

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

According to the reporter, during a open colosotomy reversal, when creating the anastomosis of the colon, the surgeon fired (squeezed) the stapler twice, and when the surgeon fired (squeezed) the second time, 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.It was also reported that the anastomosis had a leak.Another stapler was used to resolve the issue.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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

D10 concomitant product: eeaxl28, eeaxl28 eea xl 28 mm-4.8 sgl use stapler, (lot #unknown) additional information: b5, d10, g3, h11 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

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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 squeezed, 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 to resolve the 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.Another stapler was used and it had the same issue.

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
• 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: 18632086
• MDR Text Key: 334442605
• Report Number: 2647580-2024-00614
• Device Sequence Number: 1
• Product Code: GAG
• UDI-Device Identifier: 10884523006148
• UDI-Public: 10884523006148
• 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,Followup,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EEAXL2835
• Device Catalogue Number: EEAXL2835
• Device Lot Number: P3B0273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2022
• 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 Sex: Male