BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY OLSEN

    MDR report key: 15228425 · Received August 15, 2022

    Report

    Report Number
    3000719969-2022-00001
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Report Date
    August 31, 2022
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    UDI-DI
    30841785102791
    PMA / PMN Number
    K130669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED. HOWEVER, IT WAS RETURNED TO THE MANUFACTURING LOCATION FOR TESTING AND PROPER EVALUATION. THERE HAVE BEEN A TOTAL OF (B)(4) UNITS SOLD SINCE 2013 WITH ONE ADDITIONAL COMPLAINT RECORDED FOR A SIMILAR OCCURRENCE. A FOLLOW UP A REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    UPON RECEIVING THE DEVICE, IT WAS NOTED THAT THERE WAS BURNT MATERIAL ON THE TIPS OF THE DEVICE. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE TIPS SPARKED WHEN THEY WERE BROUGHT TOGETHER TO GRAB THE TISSUE AND THE ISSUE OCCURRED AGAIN OUTSIDE THE PATIENT WHEN THE SURGEON TOUCHED THE TIPS TOGETHER. THIS SPARK THAT OCCURRED WAS MOST LIKELY THE RESULT OF ARCHING OF THE DEVICE THAT WAS CAUSED BY TOUCHING THE TIPS TOGETHER OR COMING INTO CONTACT WITH METAL INSTRUMENT WHILE USING INSIDE THE PATIENT. THE RETURNED DEVICE WAS FOUND TO BE FUNCTIONING PROPERLY. A DHR REVIEW WAS COMPLETED FOR PRODUCT 20-1060K WITH LOT NUMBER 124509. THERE WERE NO NOTED NONCONFORMITIES DURING MANUFACTURING AND PROCESSING OF THIS PRODUCT AND LOT NUMBER. ALL ITEMS WERE NOTED AS WITHIN MANUFACTURING SPECIFICATION FROM THE MANUFACTURER. BASED ON THE EVALUATION OF THE DEVICE, NO FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR ADDITIONAL PERTINENT INFORMATION FOR THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT DURING THE START OF THE PROCEDURE, THE FOOT PEDAL WAS PRESSED AND THE TIPS CREATED A SPARK WHEN THEY WERE INITIAL TOUCHED TOGETHER. THE SPARK WAS REPLICATED OUTSIDE THE BODY WHEN THE DOCTOR PLACED THE TIPS TOGETHER AND STEPPED ON THE PEDAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237394 SYMMETRY OLSEN BIPOLAR FORCEPS GEI OLSEN MEDICAL LLC 124509 30841785102791

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown