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

Catalog Number ATS45

Device Problems Failure to Advance (2524); Failure to Cut (2587); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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 manufacturing record evaluation was performed, and the manufacturing criteria was met prior to the release of this batch/lot.

Event Description

It was reported that during a pediatric lap appendectomy, three staplers: the same thing happened with each of them.They were ats45 staplers, each time they were using a tr45w.No reloads will be returned.Each time they closed down on tissue and went to fire, partial staples would deploy and nothing would cut and nothing would advance.The tech said the devices did not lock out.They were able to remove the staplers without cutting them out.Case completed with a fourth device of the same product code.There were no patient consequences reported.

Manufacturer Narrative

Product complaint (b)(4).Batch # r5ax14.Investigation summary: the analysis results found that the ats45 device was received with the firing mechanism damaged and with no reload present.No functional test could be performed due to the condition of the device.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 thicker tissue than indicated or attempted to fire through 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.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: 8314742
• MDR Text Key: 136618677
• Report Number: 3005075853-2019-16424
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10705036001072
• UDI-Public: 10705036001072
• 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
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

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: 10/21/2023
• Device Catalogue Number: ATS45
• Device Lot Number: R9532H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 03/06/2019
• Patient Sequence Number: 1
• Treatment: TR45W