BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS

    MDR report key: 3022816 · Received March 27, 2013

    Report

    Report Number
    2015691-2013-19666
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    EDWARDS LIFESCIENCES,PR
    Product Code
    DXC
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE HYDRA33 INSERT WAS RECEIVED WITHOUT THE PACKAGING. AN ATTEMPT TO ATTACH THE INSERT TO THE LABORATORY CLAMP FOUND THE HYDRA INSERT TO FIT LOOSE AND THE INSERT WOULD FALL OFF BY JUST TURNING THE CLAMP OVER. THE PROXIMAL PIN APPEARED SLIGHTLY STRAIGHTER THAN THE LAB HYDRA INSERT PIN. NO SILICON OIL LEAKAGE WAS OBSERVED. RAM OPTICAL MEASUREMENT OF THE INSERT WAS FOUND TO BE OUT OF SPECIFICATION. VISUAL EXAMINATIONS WERE PERFORMED AT 10X MAGNIFICATION AND WITH THE UNAIDED EYES. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. CUSTOMER REPORT OF JAW ATTACHMENT ISSUE WAS CONFIRMED AS HAVING A RELATIONSHIP TO THE MANUFACTURING PROCESS. AN INVESTIGATION WAS OPENED TO DETERMINE THE CAUSE OF THE OUT OF SPECIFICATION CONDITION ON THE INSERTS AND IMPLEMENT ANY NECESSARY ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "HYDRA INSERT DID NOT FIT SNUGLY AND IT WAS UNABLE TO ATTACH THE INSERT BEFORE USE. THE INSERT WAS NEW AND THERE WAS NO SCAR, CRACK OR SILICONE OIL LEAKAGE NOTED ON THE INSERT.' THE REPORTER COMMENTED THAT THE INSERT WAS LOOSE-FITTING WHEN HE TESTED IT ON A SAMPLE CLAMP AT THE OFFICE. SAMPLE INSERTS WERE ALSO TESTED ON THE SAMPLE CLAMP, BUT NO PROBLEM WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125932 FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS HYDRAGRIP INSERTS DXC EDWARDS LIFESCIENCES,PR HYDRA33

    Patients

    Seq Age Sex Outcome Treatment
    1