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	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Reload - tr45w (batch # k5c43l, batch # l54t71).The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch.
Event or Problem Description
Staples malformed.During the endoscopic hepatectomy, after fired with two tr45ws, some of staples malformed with irregular shape.Suture was used to sew the wound.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/2/2018.Batch # n5307e.The analysis results found that the atw45 device was received with no apparent damaged and with two tr45w reloads present.The returned reload (tr45w - b) was fully fired and with no apparent damaged.The returned reload (tr45w - c) was partially fired 3/4 and with the lockout normal.The returned device was tested for functionality with a test reload and it fired, cut, and all the staples formed 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 condition of the reload (c) indicates that the device's firing cycle was interrupted.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.

• 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: 7572733
• Report Number: 3005075853-2018-10381
• Device Sequence Number: 16184803
• Product Code: GDW
• UDI-Device Identifier: 20705036001093
• UDI-Public: 20705036001093
• 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,Followup
• Report Date (Section B): 05/10/2018

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: 12/07/2020
• Device Catalogue Number: ATW45
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1