BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIGATOR GRASPER

    MDR report key: 1806744 · Received July 30, 2010

    Report

    Report Number
    1806744
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 30, 2010
    Manufacturer
    MINI LAP TECHNOLOGIES INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY. A 5 MM PORT WAS PLACED IN THE SUBXIPHOID REGION. A SMALL NICK WAS MADE IN THE RIGHT SIDE OF THE ABDOMEN AND AN ALLIGATOR CLAMP WAS PASSED PERCUTANEOUSLY INTO THE PERITONEAL CAVITY. THE FASCIA WAS THICK AND DURING THE INSERTION THE TIP OF THE ALLIGATOR CLAMP GOT TWISTED, IT WAS THEREFORE REMOVED AND A NEW GRASPER WAS PLACED IN ITS PLACE. SIMILARLY, A SMALL NICK WAS MADE MEDIAL IN THE RIGHT UPPER QUADRANT MEDIALLY AND ANOTHER ALLIGATOR GRASPER WAS ATTEMPTED, WAS PUSHED INTO THE PERITONEAL CAVITY. DURING THE PROCESS THE TIP GOT BENT AND FELL OFF. THE ARM OF THE GRASPER WAS SUCCESSFULLY REMOVED FROM THE PATIENT. AN ADDITIONAL 5 MM PORT WAS NOW PASSED UNDER DIRECT VISION AND A REGULAR 5 MM GRASPER WAS USED FOR FURTHER DISSECTION. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLIGATOR GRASPER LAPAROSCOPIC, SURGICAL GRASPER GCJ MINI LAP TECHNOLOGIES INC. ML 000079 *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR NO OTHER THERAPIES