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

Model Number	EEAXL2535
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic surgery,  the staples were broken.The surgeon tried another way to perform the anastomosis.There was no patient injury.
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 available for evaluation.Visual inspection noted that the visual inspection of the disengaged staple guide with proper weld marks on both the staple guide and shell head.The instrument was fully fired.Further inspection noted that the green bar was not visible in the indicator window and the safety feature was broken.The pusher fingers appeared to be intact and inspection under the microscope displayed no damage to the knife blade.The anvil of the instrument was observed to be tilted and attached to the instrument.Further inspection of the anvil cutting ring showed traces of knife impression and the ring was received completely severed.It was reported that the staple was broken.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the instrument is handled rough.If the latch is forced into disengagement prior to green indicator visibility.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: the safety will not release if the green bar is not visible in the indicator window.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: 19305612
• Report Number: 2647580-2024-02088
• Device Sequence Number: 6438195
• Product Code: GAG
• UDI-Device Identifier: 10884523006124
• UDI-Public: 10884523006124
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K221003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 07/17/2024

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
• Operator of Device: Health Professional
• Device Model Number: EEAXL2535
• Device Catalogue Number: EEAXL2535
• Device Lot Number: P3B0090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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
• Patient Sex: Unknown