BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUANTUM 2000

    MDR report key: 1914495 · Received November 24, 2010

    Report

    Report Number
    1216677-2010-00008
    Event Type
    Other
    Date Received
    November 24, 2010
    Date of Event
    September 9, 2010
    Report Date
    November 22, 2010
    Manufacturer
    COOPERSURGICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED AND REPAIRED BY (B)(4). ON (B)(6) 2010, (B)(6) SERVICE DEPARTMENT RECEIVED THE DEFECTIVE QUANTUM 2000. A (B)(6) SVC ENGINEER CHECKED THE CONTROL BOARD AND FOUND THAT "THE R9 (100 OHMS) AND C19 (104) ARE DAMAGED." BY (B)(6) 2010, THE EQUIPMENT WAS FIXED BY (B)(6) AND DELIVERED TO THE HOSPITAL. (B)(6) IS NOT AWARE OF WHAT ACTUAL REPAIRS WERE MADE TO THE UNIT. (B)(6) HAS STATED "THE EQUIPMENT WORKS WELL UNTIL NOW." (B)(6) HAS MADE MANY OF ITS OWN REPAIRS TO (B)(6) EQUIPMENT OVER THE YEARS. (B)(6) HAS NO KNOWLEDGE OF THE REPAIR HISTORY AND USE RECORD OF THIS PARTICULAR UNIT. FURTHER, ACCORDING TO OUR RECORDS, (B)(6) IS NOT AWARE OF ANY SIMILAR ADVERSE EVENT HAVING EVER OCCURRED IN ANY QUANTUM 2000 ELECTROSURGICAL UNIT PLACEMENT WORLDWIDE.

    Description of Event or Problem · 1

    BOTH THE DOCTOR AND THE PT FEEL THE ELECTRIC SHOCK DURING THE LOOP SURGERY WHEN THE DOCTOR CONTACTS THE PT'S BODY. THE PT ALSO FEELS THE ELECTRIC SHOCK WHEN THE ELECTRODE CONTACTS THE PT'S TISSUE. THE DOCTOR STOPS THE SURGERY QUICKLY AND REPORTS THE ADVERSE EVENT TO (B)(6). ADVERSE EVENT REPORTED TO COOPERSURGICAL ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM 2000 NONE GEI COOPERSURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other