MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 60MM 34CM SHAFT; STAPLE, IMPLANTABLE

Catalog Number	PSE60A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 8/16/2024.D4: batch # 542c92.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one pse60a device was returned with no apparent damage and with no reload present.The device was tested for functionality in the straight position with a test reload, however, did not achieved and complete firing sequence.During the visual inspection, when the bailout door has removed the part that pressed the actuator switch for the internal circuit on the bailout door was noted to be damaged.The device was tested for functionality with a test battery in the straight position with a test reload and a test bailout door.It achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.No conclusion could be reached as to how the bailout door became damaged.Device history review: a manufacturing record evaluation was performed for the finished device batch number 542c92, and no non-conformances were identified.
Event or Problem Description
It was reported that during the 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 60MM 34CM 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: 20002265
• Report Number: 3005075853-2024-06065
• Device Sequence Number: 4953711
• Product Code: GDW
• UDI-Device Identifier: 10705036014324
• UDI-Public: 10705036014324
• 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): 08/16/2024

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 Expiration Date: 06/30/2026
• Device Catalogue Number: PSE60A
• Device Lot Number: A9DK9P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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