MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 45MM ARTICNG LNR CUTR/WHT RLD; STAPLE, IMPLANTABLE

Catalog Number	ATW45
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # n54e23.The batch history records were reviewed and the manufacturing criteria were met prior to the release of this batch.
Event or Problem Description
Appendectomy: atw45 was fired across a tissue and it got locked.The surgeon opened ec60a and completed the transaction with it.Jjm rep were not at the case.
Additional Manufacturer Narrative
Product complaint (b)(4).Batch number: n54e23.Investigation summary: the analysis showed that the atw45 device was received with no apparent damage and with a tr45w cartridge loaded in the device.The reload was received partially fired 1/3 and with the reload lockout spring damaged.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 noted to have the proper b-formed shape.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 lock out.Firing through the lockout mechanism will break the device.Please reference the instruction for use for more information.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Additional information requested and received: can you please clarify what occurred when the device "got locked"? unknown -did the device lock-out (no staples deployed and no cut line started)? unknown as rep was not present -or, did the device start to deploy staples and cut but could not be completed (partially fire)? partially fire -was there any difficulty opening the device? if yes, how was the device removed from the patient? unknown if yes, did the jaws eventually open? unknown.

• Brand Name: 45MM ARTICNG LNR CUTR/WHT RLD
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8187272
• Report Number: 3005075853-2018-15337
• Device Sequence Number: 16643460
• Product Code: GDW
• UDI-Device Identifier: 10705036001096
• UDI-Public: 10705036001096
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2018

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: 03/20/2021
• Device Catalogue Number: ATW45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/29/2019
• Patient Sequence Number: 1