BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 10837182 · Received November 13, 2020

    Report

    Report Number
    9610612-2020-00834
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 20, 2020
    Report Date
    February 23, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: VISUAL INVESTIGATION: BOTH ELECTRODES ARE IN A USED CONDITION AND FRACTURED AT THE PROXIMAL END. THE DEVICES PROVIDED ARE IN A USED CONDITION, SIGNS OF USAGE CAN BE FOUND ON THE SURFACE. THE POINTS OF THE CERAMIC BREAKAGES EXHIBIT NO UNUSUAL STRUCTURAL CONDITIONS, NO PORES INCLUSIONS OR FOREIGN BODIES COULD BE FOUND. 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 3 (5) PROBABILITY OF OCCURRENCE 2(5)) 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. BASED UPON THE INVESTIGATIONS RESULTS THERE IS CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    DURING A GENERAL PROCEDURE THE CERAMIC AROUND THE "L" HOOK ON THE CERAMIC ELECTRODE TIP L-HK F/GK372R DEVICE WAS NOTED TO BE BROKEN ON TWO OF THE DEVICE'S TIPS. BOTH DEVICES WERE CRACKED OPEN OPENING THE SETS. THE FIRST SET, THE DEVICE WAS NOTED TO BE CRACKED/BROKEN AND THE SAME DEVICE MALFUNCTION WAS NOTED WHEN GETTING THE SECOND DEVICE AS A BACKUP. REPORTEDLY, THE EVENT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR TO A DEATH. THE REPORTED WAS NOT SURE IF THERE WAS A SURGICAL DELAY BUT WAS TOLD BY THE CUSTOMER FACILITY THAT THE EVENT DID NOT CAUSE A DELAY. THE DEVICES WERE PURCHASED FIVE DAY PRIOR TO THE REPORTED EVENT ON (B)(6) 2020. THE DEVICES ARE AVAILABLE FOR EVALUATION. THIS COMPLAINT INVOLVES A TOTAL OF TWO (2) DEVICES.

    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 THAT THERE WAS AN ISSUE WITH GK384R - CERAMIC ELECTRODE TIP L-HK F/GK372R. DURING PREPARATION FOR A GENERAL PROCEDURE, IT WAS NOTED THAT THE CERAMIC AROUND L- HOOK WAS BROKEN. IT WAS FOUND TO BE CRACKED; ANOTHER DEVICE WAS READILY AVAILABLE, AND USED FOR THE SURGERY. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301424 CERAMIC ELECTRODE TIP L-HK F/GK372R LAPAROSCOPIC SURGERY GEI AESCULAP AG GK384R

    Patients

    Seq Age Sex Outcome Treatment
    1