BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 6909102 · Received October 2, 2017

    Report

    Report Number
    9610612-2017-00477
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    August 30, 2017
    Report Date
    August 31, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. THE SURGEON WAS CAUTERIZING TISSUE WHEN THE TIP OF THE L HOOK FELL OFF. OCCURRED DURING LAPAROSCOPIC CHOLECYSTECTOMY SURGERY. NO PATIENT HARM REPORTED. SURGICAL DELAY OF 30 MINUTES REPORTED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE BROKEN OFF TIP. HERE WE FOUND A LIGHT BROWN DISCOLORATION. ADDITIONALLY WE MADE A VISUAL INSPECTION OF THE FRACTURE SURFACE. FURTHERMORE WE MADE A VISUAL INSPECTION OF THE INSPECTION OF THE INSTRUMENT AND AN INSPECTION OF THE FRACTURE SURFACE. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONAL: ACCORDING TO THE QUALITY STANDARD, A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. NO PORES OR FOREIGN BODIES COULD BE FOUND ON THE POINT OF RUPTURE. WE ASSUME A FORCED FRACTURE AS THE CAUSAL FACTOR. THERE IS THE POSSIBILITY OF PRE-DAMAGE OR SIMILAR, DUE TO PREVIOUS SURGERIES. WE ASSUME THAT THE FORCED FRACTURE WERE CAUSED DUE TO AN OVERLOAD SITUATION AND THESE WILL RESULT IN BREAKAGE. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688069 CERAMIC ELECTRODE TIP L-HK F/GK372R ENDOSCOPY GEI AESCULAP AG GK384R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other