BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRAUMATIC GRASPER (MIS)

    MDR report key: 194229 · Received October 28, 1998

    Report

    Report Number
    1921846-1998-00023
    Event Type
    Malfunction
    Date Received
    October 28, 1998
    Date of Event
    September 8, 1998
    Report Date
    September 28, 1998
    Manufacturer
    ACUFEX MICROSURGICAL, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE RETRACTION GRASPERS OF THE NON-TOOTHED TYPE WERE PLACED ON THE NECK OF THE GALL BLADDER. THERE WAS A MECHANICAL FAILURE AND THE NON-FIXED BLADE OF THE GRASPER FRACTURED AT THE NECK AND BROKE. THE PIECE WAS RETRIEVED AND X-RAY SHOWED NO REMANANTS. NO INJURY IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAUMATIC GRASPER (MIS) LAPROSCOPIC SURGICAL INSTRUMENT GAG ACUFEX MICROSURGICAL, INC. NA 888043

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR