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

Catalog Number	TR45W
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, the cartridge cannot be comfortably sitted on the jaw of the stapler.No further details were provided.No patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/3/2024 d4: batch # 320a85 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 the tr45w reload was received with no apparent damaged and partially fired 1/3 and with the reload lock out spring normal.No functional test could be performed due to the condition of the reload.The reload was loaded on a test device without difficulty.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: if a reload is not loaded, or is improperly loaded in the reload jaw, the anvil jaw will not close.If high resistance is felt when squeezing the closing trigger, check to ensure that the reload is present and the reload alignment tab is seated in the reload alignment notch.The event described could not be confirmed as the reload could be loaded without any difficulties noted.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 lockout.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.Device history review a manufacturing record evaluation was performed for the finished device batch number 320a85, and no non-conformances were identified.Additional information was requested and the following was obtained: there was no adverse impact on the patient due to the device malfunctioning.

• 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 ; PR ; 3035526892
• MDR Report Key: 19035714
• Report Number: 3005075853-2024-02588
• Device Sequence Number: 20588040
• Product Code: GDW
• UDI-Device Identifier: 10705036003182
• UDI-Public: 10705036003182
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2024

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: 07/31/2026
• Device Catalogue Number: TR45W
• Device Lot Number: 423A64
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown