BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC ELECTRODE TIP L-HK F

    MDR report key: 9179965 · Received October 11, 2019

    Report

    Report Number
    9610612-2019-00701
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Report Date
    October 11, 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

    INVESTIGATION RESULTS: THE PRODUCT IS AVAILABLE FOR INVESTIGATION DECONTAMINATED. INVESTIGATION WAS CARRIED OUT THE PICTORIAL DOCUMENTATION MICROSCOPICALLY . THE POINTS OF THE CERAMIC BREAKAGES EXHIBIT NO UNUSUAL STRUCTURAL CONDITIONS, NO PORES INCLUSIONS OR FOREIGN BODIES COULD BE FOUND. THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT THEREFORE A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. THIS KIND OF INSTRUMENT IS DESIGNED FOR DELICATE USE ONLY SINCE THE CERAMIC IS SENSITIVE TO MECHANIC LOADS. IT IS LIABLE THAT A MECHANICAL OVERLOAD SITUATION, I.E. LEVERAGE, OR A DROP CAUSED THE BREAKAGE. THE CURRENT FAILURE RATE LIES WITHIN THE ACCEPTED FAILURE RATE WHICH IS DEFINED IN THE RISK ANALYSIS.

    Description of Event or Problem · 1

    CERAMIC COATING HAS SPLIT INTRAOPERATIVELY. ACCORDING TO CUSTOMER COMPLAINT DESCRIPTION: "THE ABOVE ITEM WAS USED DURING A SURGICAL PROCEDURE AND THE CERAMIC COATING HAS SPLIT. THE USAGE OF THIS TIP IS MONITORED THROUGH OUR TRACKING SYSTEM GIVEN THAT IT HAS A LIMITED NUMBER OF USES. THE HOOK HAS BEEN USED AND REPROCESSED ON 4 OCCASIONS. NO PATIENT/USER CAME TO ANY HARM. THE PROCEDURE WAS A LAPAROSCOPIC CHOLECYSTECTOMY. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO X-RAY REQUIRED, ALL PARTS ACCOUNTED FOR AND NO OTHER MEDICATION ADMINISTERED DUE TO THIS." THE ADVERSE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975269 CERAMIC ELECTRODE TIP L-HK F REUSABLE INSTRUMENTS GEI AESCULAP AG GK384R

    Patients

    Seq Age Sex Outcome Treatment
    1