BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RULTRACT SKYHOOK

    MDR report key: 435144 · Received December 21, 2002

    Report

    Report Number
    1519227-2002-00001
    Event Type
    Malfunction
    Date Received
    December 21, 2002
    Date of Event
    November 22, 2002
    Report Date
    November 22, 2002
    Manufacturer
    PEMCO, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A NEW VERSION OF THIS SURGICAL RETRACTOR SYSTEM WAS DEVELOPED TO ADD A TILTING POST AND ROTATING EXTENDED BAR UPON REQUEST OF A PHYSICIAN/CUSTOMER. ONE UNIT WAS PRODUCED AND RELEASED FOR CLINICAL USE BY THE REQUESTING PHYSICIAN, AND THE DEVICE WAS USED FOR APPROXIMATELY ONE YEAR WITH NO REPORTED PROBLEMS. HOWEVER, THE DEVICE WAS RECENTLY BEING USED IN AN INTERNAL MAMMARY ARTERY DISSECTION PROCEDURE WHEN A WELD IN THE DEVICE CRACKED AND THE DEVICE FELL SLOWLY TO THE SURGICAL TABLE. NO INJURY OCCURRED. THE DEVICE WAS RETRIEVED AND EVALUATED BY THE MANUFACTURER. (SEE H.3./H.10). NO OTHER UNIT OF THIS DESIGN HAVE BEEN DISTRIBUTED. THIS REPORT IS CONSIDERED TO BE SUFFICIENTLY COMPLETE AND NO FOLLOW-UP REPORT IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RULTRACT SKYHOOK SURGICAL RETRACTOR GAD PEMCO, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other