MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS*45 ENDO LIN CUT RELOAD WH; STAPLE, IMPLANTABLE

Model Number	TR45W
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # u5d637.Component code: mechanical(g04).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 tr45w reload was received with no apparent damaged and partially fired 1/10 and with the reload lockout spring normal.No functional test could be performed due to the condition of the reload.As part of our quality process, the manufacturing records of this batch were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that product failure is multifactorial.The condition of the reload indicates that the device's firing cycle was interrupted.When firing the device make sure that the firing stroke is completed.Do not partially fire the device.Fire the device by squeezing the firing trigger completely until it rests on the closing trigger.Once the firing cycle has been initiated, it must be completed.If re-initiation of firing is resumed, the device will lock out.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during a vats lobectomy, a device loading the tr45w was locked out at the firing.The device was used on the blood vessel.Another cartridge was used to complete the case.There were no adverse consequences to the patient.One device will be returning.No further information is available.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 11434970
• Report Number: 3005075853-2021-01267
• Device Sequence Number: 3818270
• Product Code: GDW
• UDI-Device Identifier: 10705036003182
• UDI-Public: 10705036003182
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• 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): 02/08/2021

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: 06/23/2025
• Device Model Number: TR45W
• Device Catalogue Number: TR45W
• Device Lot Number: U40G75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1