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

Catalog Number	TR45W
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The device was received with no complaint information.Attempts were made to reconcile the device with no success resulting in the creation of a new complaint.
Additional Manufacturer Narrative
(b)(4) date sent: 6/27/2024 b3: exact event date unk, entered 1/1/2024 as only the year was provided.D4: batch # unk e1: unknown reporter 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 damage along with its opened packaging and partially fired 1/3 and with the reload lock out damaged.No functional test could be performed due to the condition of the reload.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.Device history review a manufacturing record evaluation was performed for the finished device lot number 938a01, and no non-conformances were identified.

• 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 ; * ; 3035526892
• MDR Report Key: 19625056
• Report Number: 3005075853-2024-04786
• Device Sequence Number: 6434379
• 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: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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 Catalogue Number: TR45W
• Device Lot Number: 938A01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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