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

Model Number	TRIEEA31XT
Medical Device Problem Codes	Device Slipped (1584); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a lower anterior resection, the stapler was applied through the rectum; the instrument was opened to visualize the metal bolt.The anvil was applied on the bolt, and while closing the stapler, there was some bigger effort.After the stapler was opened, the surgeon noticed that one of the three metal parts (parts of the anvil that were supposed to surround the metal bolt) was bent.The surgeon decided to replace the stapler with the same lot number to resolve the issue.The surgical time was extended to 20 minutes.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: d9, 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 staple guide noted the presence of a full complement of staples.Further inspection noted that the green bar was visible in the indicator window and the safety feature was engaged.The staple guide was observed to be attached to the instrument with no damage to the staple guide.The anvil of the instrument was observed to be not tilted and separated from the instrument.Further inspection of the anvil cutting ring showed no traces of knife impression and the ring was received intact.One of the retainer legs of the anvil was observed to be bent.Functional testing found that due to the observed retainer leg damage of the clinical anvil, an rpa representative anvil p3c0627 was attached to the center rod without difficulty prior to firing the instrument.The wing nut and safety functioned properly upon rotating the twist knob.The green bar was visible within the indicator window when the twist knob was fully closed.The instrument was applied to the appropriate test media producing acceptable results.Pusher-fingers and knife advance when the handle was squeezed and the knife cut the media cleanly and completely and a full complement of staples was deployed and properly formed.The device also produced all audible, tactile and visual indicators during the functional testing.The instrument body label was removed for evaluation of the eccentric washer assembly.Evaluation of the eccentric washer noted that it was secured.It was reported that the device has difficult approximation.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the instrument was bent.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the anvil is manipulated with excessive force during the attachment to the instrument, or if the anvil is mishandled during the removal of fitting accessories.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: do not use the instrument with 4.8mm staples on any tissue that will not comfortably compress to 2.0mm in thickness.The instrument should not be used if unusual effort is required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window.Do not turn the twist knob more than one (1) turn counterclockwise after firing.Doing so may result in difficulty in removing the device or separation of the anvil assembly.Fully extend the center shaft of the stapler by turning the twist knob counterclockwise until it stops.Mate the anvil/center rod assembly to the stapler by inserting the blunt center rod into the center shaft of the stapler and push firmly until the center rod clicks into its fully seated position.This click will be tactile and audible.Manually inspect the attachment to ensure that the center rod and stapler are fully mated.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: 21469843
• Report Number: 2647580-2025-00647
• Device Sequence Number: 8658938
• Product Code: GAG
• UDI-Device Identifier: 10884521593053
• UDI-Public: 10884521593053
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K172361
• 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
• Report Date (Section B): 05/14/2025

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: TRIEEA31XT
• Device Catalogue Number: TRIEEA31XT
• Device Lot Number: P3C0326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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