BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 11561324 · Received March 24, 2021

    Report

    Report Number
    2916714-2021-00041
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    February 26, 2021
    Report Date
    May 20, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    UDI-DI
    04038653172504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS NOT ABLE TO BE CONDUCTED BY THE MANUFACTURER AS LOT # OF THE DEVICE IN QUESTION WAS NOT KNOWN. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    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 CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, AT THE BEGINNING OF THE CASE, THE CAUTERIZER HOOK WAS FOUND TO BE MISSING. X-RAYS WERE PERFORMED TO DETERMINE IF THE HOOK WAS RETAINED IN THE PATIENT. REPORTEDLY, A SURGICAL DELAY OCCURRED AS A RESULT OF THE X-RAYS THAT WERE PERFORMED. NO EVIDENCE THAT THE FRAFMENT WAS RETAINED INSIDE THE PATIENT. ALTHOUGH AVAILABLE, THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CERAMIC ELECTRODE TIP HAD DISENGAGED INSIDE A PATIENT DURING AN OPERATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, IF AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GK384R - CERAMIC ELECTRODE TIP L-HK F/GK372R. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CERAMIC ELECTRODE TIP HAD DISENGAGED INSIDE A PATIENT DURING AN OPERATION. IT IS NOT KNOWN IF THE DEVICE FRAGMENT WAS RECOVERED. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462107 CERAMIC ELECTRODE TIP L-HK F/GK372R ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI AESCULAP AG GK384R 04038653172504

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention