BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM

    MDR report key: 1060548 · Received June 12, 2008

    Report

    Report Number
    2916714-2008-00011
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    April 17, 2008
    Report Date
    June 9, 2008
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    GCJ
    PMA / PMN Number
    K912556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AESCULAP, INC. REQUESTED THE NAME OF THE USER FACILITY; HOWEVER, AMERICAN ENDOSCOPY SVCS ADVISED THAT DUE TO PROPRIETARY REASONS, THE INFO COULD NOT BE PROVIDED. AESCULAP, INC. CONFIRMED WE WERE REQUESTING THE INFO FOR THE MED WATCH SUBMISSION, NOT FOR SALES LEADS. THE INFO WOULD NOT BE USED FOR A SALES PURPOSE. AMERICAN ENDOSCOPY SERVICES ALSO ADVISED THAT THERE WAS NOT MUCH OF A DELAY BECAUSE THE USER FACILITY HAD TWO GRASPERS IN THEIR SET AND HAD A PEEL PACK BACK UP. AESCULAP, INC. REQUESTED INFO ON HOW LONG IT TOOK TO REPAIR ANY DAMAGE CAUSED BY THE TEAR. THE ENTIRE GALL BLADDER WAS REMOVED, AS PLANNED; HOWEVER, WE WANTED INFO REGARDING ADDITIONAL STEPS TAKEN, I.E. EXTRA SUCTION, FLUSHING, DUE TO THE TEAR AND IF APPLICABLE, HOW LONG IT DELAYED SURGERY. THE INFO WAS NOT MADE AVAILABLE AT THE TIME OF THIS REPORT. DEVICE WILL NOT BE FORWARDED TO MFR FOR EVAL.

    Description of Event or Problem · 1

    PROCEDURE: LAP CHOLE. GRASPER LOCKED ONTO THE PT'S GALL BLADDER AND WOULD NOT RELEASE. THE LOCK ON THE HANDLE CAME DOWN (RELEASED); AND THE HANDLE OPENED, BUT THE JAWS WERE STILL LOCKED. THE SURGEON TRIED TO PRY THE JAWS OPEN WITH MARYLAND FORCEPS; HOWEVER, WAS UNSUCCESSFUL. HE HAD TO PULL THE GALL BLADDER UNIT IT TORE AT THE TIP OF THE INSTRUMENT. ENTIRE GALL BLADDER WAS REMOVED, AS PLANNED. REPORT INDICATED THERE WAS A MINIMAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM GCJ SMITH & NEPHEW ENDOSCOPY 8360-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention