BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RULTRACT SKYHOOK RETRACTOR

    MDR report key: 2084804 · Received April 29, 2011

    Report

    Report Number
    1519227-2011-00001
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 29, 2011
    Manufacturer
    PEMCO, INC.
    Product Code
    GAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL DID NOT GIVE A DIRECT ANSWER ON RETURNING DEVICE FOR EVAL, PEMCO BELIEVES THEY WILL NOT RETURN DEVICE FOR EVAL. THEY DID HOWEVER, ORDER NEW RAKES (HOOKS) ON (B)(4) 2011. THE HOSPITAL ALSO HAS NOT GIVEN THE S/N OF THE DEVICE INVOLVED IN THE ADVERSE EVENT. IT IS BELIEVED THAT ONE OF TWO DEVICES THE HOSPITAL HAS THAT WERE MFG IN THE 1990S IS THE DEVICE INVOLVED IN THE ADVERSE EVENT. BECAUSE OF THE LACK OF INFO GIVEN TO PEMCO, WE CANNOT DETERMINE THE CAUSE OF WHY THE TIP OF THE RAKE BROKE.

    Description of Event or Problem · 1

    PER INFO IN THE HOSPITAL REPORT SENT TO PEMCO: AT SOME POINT, DURING THE HARVESTING OF THE LEFT IMA, A TINE FROM ON ONE OF THE RETRACTOR HOOKS BROKE OFF AND FELL INTO THE SURGICAL INCISION. THIS WAS NOT DETECTED BY ANY OF THE SURGICAL TEAM MEMBERS. ONCE THE LEFT IMA WAS HARVESTED, THE RETRACTOR WAS REMOVED AND THE PT'S CABG SURGERY PROCEEDED WITHOUT FURTHER INCIDENT. AN X-RAY OBTAINED ON (B)(6) 2011 SHOWED A CURVED METALLIC OBJECT. (B)(6) (RN DIRECTOR RISK MANAGEMENT) FROM THE HOSPITAL INFORMED (B)(4) FROM RULTRACT/PEMCO, THE PT ELECTED TO HAVE SURGERY TO REMOVE THE FOREIGN BODY AND WAS REMOVED WITHOUT INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization