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

Catalog Number TR45W

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # l54l2f.Additional information requested but not received: can you please provide more details how the device was ¿defective¿? did the device lock-out (no staples deployed and no cut line started)? or, did the device partially fire (start to deploy staples and cut but could not be completed)? or, did the device staple, but not cut the tissue? did the device deliver any staples? if yes, were the staples that deployed in the tissue formed in the proper closed b-formation? if no, please explain.If the stapler did fire was the staple line complete? if no, please explain.Did the device cut? if yes, was the cut line complete? what is the current patient status? was there any patient consequence or change in the post-operative care of the patient as a result of the event (extended hospital stay, readmission, re-operation, etc.)? please explain.Investigation summary: the analysis results found that the tr45w reload was received partially fired 1/10 and with damage to the spring cartridge lockout.No functional test could be performed due to the condition of the returned 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 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.

Event Description

Event: the load was defective, not completely stapling.Product information: code: tr45w and lot: m4h120.Procedure: appendectomy.

Manufacturer Narrative

Product complaint # (b)(4).Additional information requested and received: how was the surgery finished? a new load was opened and the procedure was completed uneventfully.There was any patient harm: the patient did not suffer any damage because the surgery was uneventfully completed after opening the new load.

• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8901942
• MDR Text Key: 202676725
• Report Number: 3005075853-2019-21250
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036003182
• UDI-Public: 10705036003182
• Combination Product (y/n): N
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2019
• Device Catalogue Number: TR45W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 38 YR