MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 45MM 28CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	PCE45A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lobectomy procedure, it was observed that the device would not fire.Changed to a new one to complete the procedure.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4) date sent: 3/11/2026 d4: batch #739d12.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one pce45a device was returned with joint cover damage and with an cecr45g reload present.The reload was received partially fired 1/10.The device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence, the staple line and cut line were complete and the staples meet the staple release criteria.However, the firing speed is abnormally slow.In order to verify the condition of the internal components, the device was disassembled.Upon disassembling, the relay on pcb board was noted to be non-functional.The damage on the joint cover, it is possible that the device was attended to be pulled out from a trocar in the articulated position, resulting in the edge of the trocar damaging the joint cover.It is possible that while loading the reload, the reload was pushed farther back than the reload alignment slot resulting in the knife pushing the one-piece sled forward and locking the reload.As part of our quality process, the manufacturing records of this batch number were reviewed, and the manufacturing standards were met prior to the release of this batch as part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what may have caused the pcb board to be damaged.A manufacturing record evaluation was performed for the finished pce45a, with lot/batch number a98t3d, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 739d12, and no non-conformances were identified.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: PWRD ECH FLEX 45MM 28CM SHAFT
• 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 00969 ; * 00969 ; 3035526892
• MDR Report Key: 24571352
• Report Number: 3005075853-2026-01957
• Device Sequence Number: 9507378
• Product Code: GDW
• UDI-Device Identifier: 10705036014461
• UDI-Public: (01)10705036014461(10)A98T3D(17)280801
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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: PCE45A
• Device Lot Number: A98T3D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CECR45G
• Patient Sex: Unknown