MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL LINEAR STAPLER; STAPLE, IMPLANTABLE

Model Number	TX60G
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u5eh06.Device analysis: 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 revealed that the tx60g device arrived with the shrouds removed and damaged, the firing trigger broken, and with a reload loaded on the device.The reload was received fully fired and several damaged on the body reload near of retaining pin area.Due to the condition of the device no functional test could be performed.Further analysis shows that the closure trigger was received partially closed and the retaining pin seated on the anvil hole.The trigger was completely closed and it was open when the knob was pressed and it was opened as expected.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: squeeze the closing trigger until a click is heard.The instrument is in an intermediate position, the pin is fully seated in the anvil capturing the tissue, and the jaws are partially open.Reposition tissue within the instrument if desired.Squeeze the closing trigger and the handle fully together until a second click is heard.The closing trigger is now latched to the handle and the jaws are clamped onto the tissue, which is ready to be stapled.The firing trigger will simultaneously move down to the ready-to-fire position.Before firing, check to ensure the retaining pin is seated in the anvil.If the pin is not properly positioned, staples may not form properly, which may result in leakage or disruption of the staple line.Fire the instrument by pulling the firing trigger back completely against the closing trigger until a click is heard, signifying the staples are fully formed.The damage to the firing trigger is possible that the device encounter higher firing forces than normal resulting in a damaged component.As part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device batch/lot number, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.
Event or Problem Description
It was reported that after the release, the device could no longer be opened.Quite a bit of force was used when trying to open it.When the surgeon opened it, the retaining pin from the magazine didn¿t go back.It was then prepared out.No patient harm reported.Procedure: lower lobe resection.

• 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: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14240372
• Report Number: 3005075853-2022-02734
• Device Sequence Number: 11846767
• Product Code: GDW
• UDI-Device Identifier: 10705036003359
• UDI-Public: 10705036003359
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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: 09/30/2025
• Device Model Number: TX60G
• Device Catalogue Number: TX60G
• Device Lot Number: U40P4C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown