BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL GENERATOR

    MDR report key: 1191263 · Received October 9, 2008

    Report

    Report Number
    1527736-2008-03642
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: BASED ON THE ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THE MAIN PCB WAS CAUSING THE UNIT TO LOSE DISPLAY INTERMITTENTLY. TO CORRECT THIS ISSUE, THE ANALYSIS SITE REPLACED THE MAIN PCB. THE SITE ALSO FOUND THE DISPLAY ON THE BEZEL SUB-ASSEMBLY WAS DAMAGED AND TO CORRECT THIS ISSUE, THE ANALYSIS SITE REPLACED THE BEZEL SUB-ASSEMBLY. PER THE SERVICE MANUAL, CALIBRATION AND TEST WERE PERFORMED WITH THE UNIT PASSING ALL TESTS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY ON THE GENERATOR WOULD DISAPPEAR WHEN SOMEONE TAPPED ON THE DISPLAY. THE GENERATOR WAS SWAPPED PRIOR TO THE START OF AN UNK CASE AND THE CASE WAS COMPLETED WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL GENERATOR NONE LFL ETHICON ENDO SURGERY, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE