BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 9219219 · Received October 22, 2019

    Report

    Report Number
    9610612-2019-00721
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Report Date
    October 22, 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: THE INSTRUMENT ARRIVED WITH THE BROKEN OFF PART IN A DECONTAMINATED CONDITION AND IT IS AVAILABLE FOR INVESTIGATION. INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT VISUALLY AND MICROSCOPICALLY WITH A DIGITAL MICROSCOPE. WE MADE A VISUAL INSPECTION OF THE INSTRUMENT. HERE WE FOUND A BROKEN OFF HOOK. ADDITIONALLY WE MADE AN OPTICAL INSPECTION OF THE FRACTURE SURFACE. NO ABNORMALITIES WERE DETECTED. FURTHERMORE WE MADE A VISUAL INSPECTION OF THE BROKEN OFF HOOK AND OF THE FRACTURE SURFACE. NO ABNORMALITIES WERE DISCOVERED. BATCH HISTORY REVIEW: THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONALE: ACCORDING TO THE QUALITY STANDARD A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. NO PORES OR INCLUSIONS COULD BE FOUND ON THE POINT OF RUPTURE. INVESTIGATIONS LEAD TO THE ASSUMPTION THAT THE BREAKAGE WAS CAUSED BY A MECHANICAL OVERLOAD SITUATION OR FORCED FRACTURE DUE TO AN IMPROPER HANDLING. ADDITIONALLY THERE IS THE POSSIBILITY FOR PRE-DAMAGE OR SIMILAR DUE TO PREVIOUS SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PRODUCT CERAMIC ELECTRODE TIP L-HK F. THE CERAMIC ON THE HOOK TIP BROKE DURING THE SURGICAL PROCEDURE. THE HOOK TIP HAS ONLY BEEN USED ON 4 OCCASIONS. A LAPAROSCOPIC GENERAL SURGERY WAS BEING CARRIED OUT. THERE WAS NO PATIENT HARM. THE BROKEN HOOK TIP WAS FOUND. THE ADVERSE MALFUNCTION IS FILED UNDER AAG (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012773 CERAMIC ELECTRODE TIP L-HK F/GK372R LAPAROSCOPIC SURGERY GEI AESCULAP AG GK384R

    Patients

    Seq Age Sex Outcome Treatment
    1