BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC ELECTRODE TIP J-HK F/GK372R

    MDR report key: 10928780 · Received December 1, 2020

    Report

    Report Number
    9610612-2020-00847
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 3, 2020
    Report Date
    February 17, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    UDI-DI
    04038653172498
    PMA / PMN Number
    K970541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY X PROBABILITY OF OCCURRENCE) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS THERE IS CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO AESCULAP INC. THAT A CERAMIC ELECTRODE TIP (PART # GK383R) WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, CERAMIC INSULATION WAS OBSERVED TO BE MISSING FROM THE SHAFT, NEAR THE DISTAL TIP OF THE DEVICE. HOWEVER, THE DAMAGE WAS NOT IDENTIFIED BY THE SURGICAL STAFF UNTIL THE DEVICE WAS ON THE BACK TABLE, SO NO DETERMINATION COULD BE MADE AS TO WHEN THE DAMAGE OCCURRED. AN X-RAY WAS PERFORMED, BUT NO FRAGMENTS WERE IDENTIFIED. ADDITIONALLY, THE SURGICAL STAFF CHECKED THE PATIENT, AND CONFIRMED THAT NO PIECES WERE PRESENT. THE SURGERY WAS DELAYED FOR AN UNSPECIFIED AMOUNT OF TIME DUE TO THE X-RAYS THAT WERE PERFORMED. THE DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE XC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395290 CERAMIC ELECTRODE TIP J-HK F/GK372R ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI AESCULAP AG GK383R 04038653172498

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention