BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 19361372 · Received May 21, 2024

    Report

    Report Number
    2916714-2024-00084
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    April 23, 2024
    Report Date
    October 3, 2024
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    UDI-DI
    04038653172504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLES PROVIDED WAS RETURNED TO THE MANUFACTURING SITE FOR TECHNICAL EVALUATION. THROUGH VISUAL EXAMINATION, IT WAS OBSERVED THAT THE SAMPLE HAD A BROKEN OFF HOOK AND THE BROKEN OFF HOOK WAS NOT ENCLOSED. THROUGH MICROSCOPIC EVALUATION, THE CERAMIC INSULATION/BODY WAS IN GOOD CONDITION, WITHOUT CRACKS OR CHIPPED-OFF PARTS. THE FRACTURE SURFACE ON THE BODY IS TYPICAL FOR AN OVERLOAD FRACTURE. NO PARTS WERE MISSING. BASED ON THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE FRACTURE SURFACE SHOWS NO SIGNS OF A MATERIAL FAILURE OR MANUFACTURING ERROR. EACH ELECTRODE IS 100% MECHANICALLY AND ELECTRICALLY TESTED BEFORE DELIVERY, SO A PRODUCTION- RELATED ERROR CAN BE RULED OUT. AS A RESULT, THE REPORTED FAILURE COULD NOT BE CONFIRMED TO BE A MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC. THAT A CERAMIC ELECTRODE TIP L-HK F/GK372R (PART # GK384R) WAS USED DURING A LAPAROSCOPIC PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THE TIP OF DEVICE BROKE OFF INTO PATIENT. REPORTEDLY THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PART. A SURGERY DELAY OF A FEW MINUTES WAS REPORTED. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220447 CERAMIC ELECTRODE TIP L-HK F/GK372R HANDHELD PRODUCTS & LIGATION GEI AESCULAP AG GK384R 04038653172504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention