BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RULTRACT SKYHOOK RETRACTOR

    MDR report key: 473453 · Received July 22, 2003

    Report

    Report Number
    1519227-2003-00001
    Event Type
    Malfunction
    Date Received
    July 22, 2003
    Date of Event
    December 16, 2002
    Report Date
    December 16, 2002
    Manufacturer
    PEMCO, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED TO THE MFR FOR ROUTINE SERVICE 11/22/02. FOLLOWING RETURN OF THE DEVICE TO THE HOSP AFTER SERVICING, THE DEVICE WAS BEING USED IN SURGERY WHEN THE RAKE PLATE ASSEMBLY FELL ONTO THE PT. THE HOSP'S SERVICE REQUEST STATES THAT THE DEVICE "CAME APART AND THE RAKE PART FELL ONTO PT'S HEART." THE DEVICE WAS RETUREND AGAIN TO THE MFR, FOR EVAL IN 12/2002, AND THE RETRACTOR CABLE SET SCREEN WAS FOUND TO BE LOOSE. SUCH A CONDITION COULD ALLOW THE RAKE PLATE ASSEMBLY TO FALL. IT IS POSSIBLE THAT THE REQUESTED SET SCREEN TIGHTENING WAS NOT PERFORMED BY THE MFR DURING THE PREVIOUS SERVICING OF THE DEVICE. ACCORDING TO HOSP STAFF THE PT SUSTAINED NO INJURY FROM THE REPORTED EVENT. THE PT DIED SUBSEQUENT TO SURGERY, BUT THE HOSP STAFF INDICATED THAT THE REPORTED EVENT DID NOT CAUSE OR CONTRIBUTE TO THE PT'S DEATH. TO PREVENT RECURRENCE OF THIS PROBLEM, THE MFR IS INITIATING IMPROVED SERVICING PROCEDURES AND TRAINING. THIS REPORT IS CONSIDERED COMPLETE AND NO FOLLOW-UP REPORT IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RULTRACT SKYHOOK RETRACTOR SURGICAL RETRACTOR GAD PEMCO, INC. 4100-IMR-6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR