BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 3799669 · Received April 22, 2014

    Report

    Report Number
    2916714-2014-00290
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    December 4, 2013
    Report Date
    April 22, 2014
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(6) 2014. MANUFACTURING SITE EVALUATION: NO PRODUCT HAS BEEN RECEIVED FOR EVALUATION. ATTEMPTS WERE MADE TO OBTAIN DEVICE, DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). UNAVOIDABLE BURNS TO LIVER DUE TO LAPAROSCOPIC DIATHERMY HOOK. INCIDENT OCCURRED TWICE. FAULTY HOOKS WITHDRAWN FROM USE AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242560 CERAMIC ELECTRODE TIP L-HK F/GK372R ELECTROSURGICAL INSTRUMENT GEI AESCULAP AG & CO. KG GK384R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other