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	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent 10/30/2024 d4 batch #940c81 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 size indicator on avil blurred and with no reload present.The device was returned with a non-working firing mechanism.No further functional test could be performed due to the condition of the device.In order to verify the condition of the internal components, the device was disassembled.Upon disassembling, the black motor wire was noted to be disassembled from the motor terminal, therefore making the device non-functional.Based on the information currently available, a product issue was identified during the investigation of the sample received.The damage to the device is potentially related to a manufacturing process.This product issue will be addressed through ethicon endo surgery¿s quality system.A manufacturing record evaluation was performed for the finished device batch number 940c81, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished pce45a, with lot/batch number c9dx2n, and no non-conformances were identified.
Event or Problem Description
It was reported that during a lung resection surgery, could not fire without motor sound.The surgeon removed the battery and rotated for 180 degree and reinserted the battery.The device still could not fire and without motor sound.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided. .

• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20567732
• Report Number: 3005075853-2024-08216
• Device Sequence Number: 7988475
• Product Code: GDW
• UDI-Device Identifier: 10705036014461
• UDI-Public: (01)10705036014461(17)270331(10)C9DX2N(21)
• 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): 10/30/2024

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 Catalogue Number: PCE45A
• Device Lot Number: C9DX2N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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