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

Model Number	PCE45A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # u5ck2x.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 pce45a device was returned with no apparent damage and with the manual override door out of position; the override lever was up which denotes that the knife was manually returned to home position.It should be noted after the manual override system is used the instrument is disabled and cannot be used for any subsequent firings.An ecr45g reload (b) and another ecr45d reload (c) were received.The reload (b) was received fully fired and the reload (c) was received unfired, with 1 double driver out of position, making it non-functional.In addition the reload pan (c) was noted to be partially dislodged from the right proximal side, and the one piece sled was out of position.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.It should be noted that product failure is multifactorial.No conclusion could be reached on what may have caused the reload pan to dislodge.
Event or Problem Description
It was reported that during vats right upper lobe resection surgery, could not fire when severing lung tissue on the second firing.Changed another device, still could not fire.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can 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
• MDR Report Key: 11553992
• Report Number: 3005075853-2021-01543
• Device Sequence Number: 11784094
• Product Code: GDW
• UDI-Device Identifier: 10705036014461
• UDI-Public: 10705036014461
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: 04/30/2023
• Device Model Number: PCE45A
• Device Catalogue Number: PCE45A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1