BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 297036 · Received September 19, 2000

    Report

    Report Number
    1527736-2000-04443
    Event Type
    Malfunction
    Date Received
    September 19, 2000
    Date of Event
    August 29, 2000
    Report Date
    August 29, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) LCSC5 WAS USED WITH THE LUKE HANDPIECE DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED BY THE REP THE DEVICE HAD A SOLID LOCK OUT. THE SURGEON IS A VERY EXPERIENCE HARMONIC USER AND TRIED EVERY TROUBLESHOOTING TIP TO PREVENT REMOVING THE SHEAR DURING THE PROCEDURE. THE SURGEON PUNCTURED THE GALL BLADDER CAUSING NO HARM TO PT. THE SURGEON OPENED ANOTHER C-5 TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE ULTRASONIC-SURGERY DEVICES - ENDOSC LFL ETHICON ENDO-SURGERY - ALB NA N4J117

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other