BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKLINE

    MDR report key: 1506991 · Received September 29, 2009

    Report

    Report Number
    1506991
    Event Type
    Malfunction
    Date Received
    September 29, 2009
    Date of Event
    June 16, 2009
    Report Date
    September 29, 2009
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC GASTRIC BYPASS, SURGEON BELIEVED GRASPER WAS BROKEN. A SMALL METAL PIECE WAS NOTED EXTERNAL TO THE PATIENT. INSTRUMENT GIVEN TO STRYKER TECH. X-RAYS OF ABDOMEN READ AS NEGATIVE FOR FOREIGN BODY. NEXT DAY PIECE OF METAL, APPROXIMATELY 2MM/1MM/1/2MM PIECE WAS NOTED ON X-RAY. UNCLEAR IF FROM GRASPER. PATIENT WAS WAS NOTIFIED. POTENTIAL FOR FURTHER HARM WAS UNLIKELY, SO DECISION WAS MADE NOT TO RETRIEVE THE METAL PIECE.

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC GASTRIC BYPASS, SURGEON BELIEVED GRASPER WAS BROKEN. A SMALL METAL PIECE WAS NOTED EXTERNAL TO THE PATIENT. INSTRUMENT GIVEN TO STRYKER TECH. X-RAYS OF ABDOMEN READ AS NEGATIVE FOR FOREIGN BODY. NEXT DAY PIECE OF METAL, APPROXIMATELY 2MM/1MM/1/2MM PIECE WAS NOTED ON X-RAY. UNCLEAR IF FROM GRASPER. PATIENT WAS WAS NOTIFIED. POTENTIAL FOR FURTHER HARM WAS UNLIKELY, SO DECISION WAS MADE NOT TO RETRIEVE THE METAL PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLICKLINE GRASPING FORCEPS GCJ KARL STORZ ENDOSCOPY-AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR