BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 9324206 · Received November 14, 2019

    Report

    Report Number
    9610612-2019-00765
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Report Date
    November 13, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION AND INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH CERAMIC ELECTRODE . IT WAS REPORTED THAT THE OPERATING THEATRES HAVE EXPERIENCED 2 MORE DEVICES FAILING DURING USE. ONE APPEARS TO HAVE "EXPLODED" AS ALL THE CERAMIC HAS COME AWAY FROM THE TIP; THE SURGEON CONFIRMED ALL PARTS WERE FOUND. A SECOND HAS THEN HAD PART OF THE CERAMIC TIP COME AWAY. IT WAS CONFIRMED BOTH INSTRUMENTS HAVE BEEN USED 7 TIMES AND REPROCESSED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). ALL OF THE PIECES WERE FOUND. THERE WAS NO PATIENT HARM. AN ADDITIONAL MEDICAL INTERVENTION WAS NOT NECESSARY. THERE ARE NO SURGICAL DELAYS. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2019-00764 ( (B)(4) GK 384R).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115639 CERAMIC ELECTRODE TIP L-HK F/GK372R LAPAROSCOPIC SURGERY GEI AESCULAP AG GK384R

    Patients

    Seq Age Sex Outcome Treatment
    1