BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS STAPLER

    MDR report key: 3864181 · Received June 10, 2014

    Report

    Report Number
    3005075853-2014-03900
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNCUT WASHER - UNBLEMISHED. THE ANALYSIS RESULTS FOUND THAT THE CDH25A DEVICE ARRIVED IN GOOD VISUAL CONDITION VOID OF STAPLES AND WITH THE BREAKAWAY WASHER UNCUT, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE, THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE OR THE ANVIL WAS NOT REATTACHED CORRECTLY. IT SHOULD BE NOTED THAT BEFORE FIRING, ENSURE THAT THE ORANGE INDICATOR IS FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE AND THE ANVIL IS REATTACHED CORRECTLY. TO REATTACH THE DETACHABLE HEAD OR ANVIL DO NOT CLAMP ACROSS OR GRIP ON THE LOCKING SPRINGS AS IT MIGHT NOT CLICK INTO PLACE. NOT REATTACHING THE ANVIL CORRECTLY OR THE ORANGE INDICATOR NOT BEING SET ON THE GREEN RANGE WILL RESULT IN A BIGGER GAP BETWEEN THE ANVIL AND THE GUIDE FACE, THEREFORE THE STAPLES WILL NOT HIT THE ANVIL TO MAKE B- FORMED STAPLES. IN ADDITION IF THE FIRING SEQUENCE IS NOT COMPLETE, STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY; THE DEVICE FORMED ALL THE STAPLES, AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: UPON REVIEW OF THE ADDITIONAL INFORMATION RECEIVED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND HAS BEEN REVISED TO NOT REPORTABLE

    Additional Manufacturer Narrative · 1

    (B)(4). 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. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WAS THE CUT LINE FULLY CIRCUMFERENTIAL AROUND THE TARGET TISSUE? DID THE DEVICE STAPLE THE TISSUE? WERE THERE STAPLES MISSING FROM THE STAPLE LINE? WHAT WAS THE APPEARANCE OF THE STAPLES THAT WERE DEPLOYED ON THE TISSUE? WHAT CONFIRMATION WAS RECEIVED THAT THE DEVICE WAS FULLY FIRED?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLING WAS NOT COMPLETED SECURELY THAT THE SURGEON HAD TO SWITCH TO ANOTHER DEVICE. AFTER FIRING, IT WAS OBSERVED THE STAPLING WAS NOT DONE COMPLETELY. FORTUNATELY, NO OTHER HARMFUL EVENT TO PATIENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338092 PROXIMATE ILS STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1