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)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u5em0t.(b)(4).Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection was conducted on the return reload.Visual analysis of the returned sample determined that the tr45w reload was received with no apparent damaged and partially fired 1/10 and with the reload lock out damaged.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.The event reported was confirmed and it is related to improper use of the reload.The damage to the reload lockout spring is consistent with damage observed when the firing cycle is started, interrupted, released, and restarted.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 the 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.
Event or Problem Description
It was reported that the device failed to fire.Didn't activate at all.No patient consequences reported.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/6/2022 this is an an individual medical device report that was originally submitted in error as voluntary malfunction summary reporting.H1 - summary report and noe fields should be blank as this is an an individual medical device report.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12558201
• Report Number: 3005075853-2021-05837
• Device Sequence Number: 19107886
• 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): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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 Model Number: TR45W
• Device Catalogue Number: TR45W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown