MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ETS*ENDO ARTICU LIN CUTTER WHI; STAPLE, IMPLANTABLE

Catalog Number	ATW35
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation: the analysis showed that the atw35 device was received with tyvek present, no apparent damage and with a tr35w reload loaded in the device.The reload was received partially fired 1/3 and with the reload lock out spring damaged.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 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.The returned device was tested for functionality with a test reload and it fired, cut and formed all the staples as intended.The device fired without any difficulties, the staple line was complete and the staples were note to have the proper b-formed shape.The batch history record was reviewed and no protocols or ncr related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during a lap nephrectomy procedure, the stapler locked out prior to first firing.Opened stapler, removed from renal vein, no staples or cut line.Opened like device was fired, worked as indicated.There were no patient consequences reported.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7084987
• Report Number: 3005075853-2017-06476
• Device Sequence Number: 19199041
• Product Code: GDW
• UDI-Device Identifier: 20705036012327
• UDI-Public: 20705036012327
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2017

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: 03/31/2021
• Device Catalogue Number: ATW35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1