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

Model Number	EEAXL25
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Fire (2610); Detachment of Device or Device Component (2907); Packaging Problem (3007)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Breakdown (2681)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a laparoscopic closure of end-colostomy with anastomosis to colon procedure, while reconnecting th e colon with a circular stapler, a big crack appeared in the stapler when the surgeon fired it, and the plastic from the stapler fell into the patient's cavity.All the pieces were retrieved.There was difficulty removing the stapler from the cavity, and due to the stapler breaking down, it was very hard to remove.There was a tear in the mesorectal area upon removal of the stapler.To resolve the issue, a new stapler was used, and the torn tissue was sutured.The surgical time was extended due to the product problem.The event led to or extended the patient's hospitalization.Upon inspection there were found severe damage to the outer-packaging material.Inner packing was not visually damaged.
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.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but four phots were available for evaluation.Visual inspection noted that the photos were displayed box with damage.It was reported that there was a packaging damaged.The reported issue was confirmed.The most likely cause could not be established from the information available.It was also reported that the instrument broke, the component was disengaged, the device was difficult to remove from the cavity and instrument did not fire.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: 19282287
• Report Number: 2647580-2024-02045
• Device Sequence Number: 7659519
• Product Code: GAG
• UDI-Device Identifier: 10884523006056
• UDI-Public: 10884523006056
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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,Followup,Followup
• Report Date (Section B): 11/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EEAXL25
• Device Catalogue Number: EEAXL25
• Device Lot Number: P2K0317
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 08/22/2024; 11/18/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 08/26/2024; 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Female