BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH A GRASPER

    MDR report key: 164258 · Received April 23, 1998

    Report

    Report Number
    1527736-1998-01254
    Event Type
    Malfunction
    Date Received
    April 23, 1998
    Date of Event
    March 13, 1998
    Report Date
    March 13, 1998
    Manufacturer
    SYMBIOSIS CORP.
    Product Code
    KNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING # 50904. SENT: 12/02/1998. 12/02/1998 AFTER FURTHER INVESTIGATION, THIS COMPLAINT WAS DETERMINED TO BE NOT REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DSG23 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE TIP OF THE GRASPER BROKE WHILE ATTEMPTING TO GRASP THE GALL BLADDER. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH A GRASPER GRASPER KNS SYMBIOSIS CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other