MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. POWERED PLUS LONG 45; STAPLE, IMPLANTABLE

Catalog Number	PLEE45A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an omega loop procedure, the instrument could not be used.Remains nonfunctional after insertion.Suspicion for battery contact failure.No patient harm nor significant delay reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/30/2025.D4: batch #904c63.Investigation summary the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one plee45a device was returned with no apparent damage and with two gst45b reloads present.The reload (b) was received partially fired 1/4.The reload (c) was received partially fired 1/4 with the reload pan partially dislodged and the reload body broken.It is possible that the damage noted on the returned reload was due to improper handling of the reload.Upon visual inspection, the manual override door was noted to be out of position; however, the bailout system was not activated.As additional testing, the bailout door was installed and then, the device was tested for functionality in the straight position with a returned reload (b) and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.The partially fired is consistent with an incomplete or interrupted cycle.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 904c63, and no non-conformances were identified.Additional information was requested and the following was obtained: did the device lock-out (no staples deployed and no cut line started)? did not work at all.Yes did not work at all.Or, did the device start to deploy staples and cut but could not be completed (partially fire)? n/a.Or, did the device fully fire and stop during the automatic knife return? n/a.Was there any difficulty opening the device? no.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: POWERED PLUS LONG 45
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21939253
• Report Number: 3005075853-2025-03157
• Device Sequence Number: 7893186
• Product Code: GDW
• UDI-Device Identifier: 10705036015345
• UDI-Public: (01)10705036015345(17)270228(10)C9DR75
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K163454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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 Catalogue Number: PLEE45A
• Device Lot Number: C9DR75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GST45B (X2)
• Patient Sex: Unknown