BEUDAMED
    FDA Adverse Event Other Summary report: N

    RULTRACT SKYHOOK RETRACTOR SYSTEM

    MDR report key: 1282748 · Received January 5, 2009

    Report

    Report Number
    1519227-2008-00001
    Event Type
    Other
    Date Received
    January 5, 2009
    Date of Event
    December 3, 2008
    Report Date
    December 23, 2008
    Manufacturer
    PEMCO, INC.
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE OF 4/1988 IS FOR S/N (B) (4) AND IS THE ORIGINAL SHIP DATE, S/N (B) (4) WAS ORIGINALLY SHIPPED IN 4/1991. (B) (6) PICKED UP THE TWO SUSPECT RATCHETS AND DISCUSSED THE EVENT WITH THE HOSPITAL PERSONNEL, (B) (6). THEY DETERMINED THAT THE MOST LIKELY CAUSE OF THE INCIDENT WAS A NEW NURSE WHO HAD NOT BEEN PROPERLY TRAINED ON THE EQUIPMENT, OPERATED THE EQUIPMENT. ATTACHED IS A REPORT FROM (B) (6). (B) (6) CEO OF (B) (6) TRIED TO GET ADDITIONAL INFO ABOUT THE INCIDENT FROM THE HOSPITAL, BUT THE HOSPITAL WOULD NOT GIVE HER ANY ADDITIONAL INFO. (B) (6) WAS TOLD THAT SHE WOULD HAVE TO SPEAK TO A SUPERVISOR TO GET THE INFO SHE WANTED AND WAS TOLD THAT THE SUPERVISOR WOULD CALL HER. THE SUPERVISOR NEVER CALLED AND (B) (6) TRIED SEVERAL MORE TIMES TO GET THE INFO BUT NONE WAS GIVEN.

    Description of Event or Problem · 1

    (B) (6) HOSPITAL REPORTED THAT THE RAKE PLATE FROM A (B) (4) RETRACTOR FELL, AND REQUESTED A COMPANY REPRESENTATIVE TO INSPECT THE PRODUCT. HOSPITAL DID NOT KNOW IF THE PRODUCT (RATCHET) RESPONSIBLE WAS SERIAL # (B) (4) OR (B) (4), SO BOTH WERE SENT TO PEMCO FOR EVAL. BOTH RATCHETS WORKED PROPERLY. IT WAS LATER DISCOVERED ON (B) (6) 2008, BY PEMCO THAT WHEN THE RAKE PLATE FELL, IT FELL INTO THE PT'S CHEST "NICKING" THE PT'S HEART. PEMCO WAS TOLD THAT IT WAS NOT SERIOUS, AND IS NOT AWARE OF WHAT IF ANY ACTION WAS NEEDED TO REPAIR ANY INJURY SUSTAINED BY THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1