BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM X 32CM STRYKEPROBE OUTER SHEATH REPLACEMENT

    MDR report key: 2860337 · Received November 5, 2012

    Report

    Report Number
    2936485-2012-00544
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 10, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K963765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER 0250070460 WITH A QUANTITY OF THREE (SAME PART AND LOT NUMBER), WERE IMPLICATED IN THIS EVENT. PLEASE REFER TO MEDWATCH REPORT NUMBER 2936485-2012-00543 FOR THE REPORTING OF UNIT #1 AND MEDWATCH REPORT NUMBER 2936485-2012-00542 FOR PART NUMBER 0250070446, ALSO IMPLICATED IN THIS EVENT. ADDITIONAL WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC MONOPOLAR SPATULA TIP. THE SHEATH WAS GETTING SO HOT THAT IT WAS MELTING. THE SURGEON HAD TO USE THREE DIFFERENT SHEATHS DURING THE PROCEDURE. FURTHER, THE PROCEDURE WAS COMPLETED WITHOUT ANY ADVERSE CONSEQUENCES TO THE PT. THE PT TO RECOVER IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM X 32CM STRYKEPROBE OUTER SHEATH REPLACEMENT GEI STRYKER ENDOSCOPY SAN JOSE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK