BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH CURVED SCISSORS

    MDR report key: 3839455 · Received May 29, 2014

    Report

    Report Number
    3005075853-2014-03641
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K984240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT INDICATED A HOLE WHERE THE ROTATION KNOB RUBS AGAINST THE PACKAGING. THE 5DCS PACKAGE WAS VISUALLY EXAMINED. DENTS IN THE FMP LID STOCK WERE PRESENT IN THE AREA OF THE KNOB. THE PACKAGE WAS OPENED TO VIEW THE AREA UNDER MAGNIFICATION AND FMP APPEARED TO BE INTACT. THE DAMAGED AREAS WERE DYE TESTED PER TM5016 AND NO SEAL INTEGRITY DEFECT WAS IDENTIFIED. THE DYE POOLED ON THE MATERIAL AND DID NOT FLOW THROUGH. THIS INDICATES THAT NO HOLE WAS PRESENT. THE FMP MATERIAL IS FLEXIBLE AND HAD BECOME STRETCHED AND OVER THE KNOB AREA, BUT NO BREACH OF STERILITY OCCURRED. THE ISSUE IS COSMETIC ONLY. THE COMPLAINT EVENT FOR A HOLE IS NOT CONFIRMED.

    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.

    Description of Event or Problem · 1

    PACKAGINE ISSUE: IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, ON THE BACKSIDE OF THE PACKAGING, THERE IS A TINY HOLE WHERE THE ROTATION KNOB RUBS AGAINST THE PACKAGING. THIS HAS RENDERED THE ITEM UNSTERILE. THE PROCEDURE WAS COMPLETED USING SAME LIKE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316414 ENDOPATH CURVED SCISSORS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA L4E59Y

    Patients

    Seq Age Sex Outcome Treatment
    1