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

Catalog Number ATS45

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2018

Event Type  malfunction  

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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

The second row of staples did not slide.Use of another device to complete the procedure.No patient consequence.

Manufacturer Narrative

Product complaint # (b)(4).Batch number: r57w9g.Investigation summary: the analysis showed that the ats45 device was received with no apparent damage and with a tr45w cartridge loaded in the device.The reload was received partially fired 1/4 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: ETS FLEX ARTICNG LNR CUTR 45MM
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8080910
• MDR Text Key: 128277730
• Report Number: 3005075853-2018-14432
• Device Sequence Number: 0
• Product Code: GDW
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2023
• Device Catalogue Number: ATS45
• Device Lot Number: R93T9H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 02/25/2019
• Patient Sequence Number: 1