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

Catalog Number ATS45

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: the analysis results found that the ats45 device was received with the firing mechanism damaged and with (b)(4) cartridge loaded in the device.The reload was received partially fired and with the lockout spring normal.No functional test could be performed due to the condition of the device; however, the device closed and opened properly during testing.The device was disassembled to verify the condition of the internal components and the firing trigger teeth were found broken.No conclusion could be reached on what caused the firing mechanism to fail, it is possible that the device was attempted to fire on ticker tissue then indicated or attempted to fire trough a locked reload in previous firings causing an increase of the internal forces resulting in the component yielding.It should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require specifications; in addition, a sample of the batch is inspected at fgqa.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Attempts were made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you please clarify what was meant by, ¿the device was defective¿? did the device deliver any staples? if yes, were the staples formed properly? if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? if yes, was there any issue with the cut line such as jagged, dull knife, irregular, etc? on which firing did this event occur (1st, 2nd, 12th, etc.)? were any unexpected noises heard? if so, when? were any of the forces higher or lower than expected (closing, firing, or opening)? was there any patient consequence or change in the post-operative care of the patient as a result of the event?.

Event Description

It was reported that during a laparoscopic appendectomy procedure the device was defective.The procedure was completed using a like device of the same product code.No additional information was available at the time of the call.There were no patient consequences reported.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7096782
• MDR Text Key: 95059584
• Report Number: 3005075853-2017-06538
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20705036001079
• UDI-Public: 20705036001079
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2022
• Device Catalogue Number: ATS45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1