BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC ELECTRODE TIP J-HK F/GK372R

    MDR report key: 8371849 · Received February 26, 2019

    Report

    Report Number
    9610612-2019-00119
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    February 6, 2019
    Report Date
    March 5, 2020
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    PMA / PMN Number
    K970541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: B5. INVESTIGATION: A VISUAL INSPECTION WAS MADE OF THE INSTRUMENT. HERE WE FOUND A BENT SHAFT AND GROVES. NEXT, WE DISASSEMBLED THE INSTRUMENT AND MADE A VISUAL INSPECTION OF THE CERAMIC ELECTRODE GK38R. HERE WE FOUND A BROKEN OFF AREA. BATCH HISTORY REVIEW THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS ARE NOT POSSIBLE. CONCLUSION AND ROOT CAUSE THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABILITY USAGE RELATED. RATIONALE 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. INVESTIGATIONS LEAD TO THE ASSUMPTION THAT THE CERAMIC BREAKAGE AND BENT SHAFT WERE CAUSED BY A MECHANICAL OVERLOAD SITUATION DUE TO AN IMPROPER HANDLING. NO CAPA NECESSARY.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. PLEASE PROVIDE PATIENT INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ADDITIONAL EVENT INFORMATION WAS RECEIVED: PER THE REPORTER, THERE WAS MINIMAL DELAY IN SURGERY AND X-RAYS WERE NOT REQUIRED FOR PIECE RETRIEVAL FROM THE ABDOMEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IO TIP OF ELECTRODE BROKE OFF. J TIP FELL INTO PATIENT. TIP WAS RECOVERED. AS PER SUBMISSION, THIS INCIDENT DID NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. THIS INCIDENT DID CONTRIBUTE TO AN UNKNOWN AMOUNT OF TIME IN SURGERY. THIS WAS A LAP PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164335 CERAMIC ELECTRODE TIP J-HK F/GK372R REUSABLE INSTRUMENTS GEI AESCULAP AG GK383R UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention