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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. ETS FLEX ARTICNG LNR CUTR 45MM; STAPLE, IMPLANTABLE Back to Search Results
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.
 
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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 Key8314742
MDR Text Key136618677
Report Number3005075853-2019-16424
Device Sequence Number1
Product Code GDW
UDI-Device Identifier10705036001072
UDI-Public10705036001072
Combination Product (y/n)N
PMA/PMN Number
K020779
Number of Events Reported1
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 Date10/21/2023
Device Catalogue NumberATS45
Device Lot NumberR9532H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2019
Initial Date Manufacturer Received 01/14/2019
Initial Date FDA Received02/07/2019
Supplement Dates Manufacturer Received02/07/2019
Supplement Dates FDA Received03/06/2019
Patient Sequence Number1
Treatment
TR45W
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