BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY OLSEN

    MDR report key: 15650915 · Received October 21, 2022

    Report

    Report Number
    3000719969-2022-00002
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 21, 2022
    Report Date
    October 21, 2022
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K130669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING THE COMPLAINT, PRODUCT FROM THE SAME LOT WAS REMOVED FROM INVENTORY FOR TESTING. WHILE THERE WAS DETERMINED TO BE SOME VARIATIONS OF FORCE NEEDED TO REMOVE THE BIPOLAR FORCEPS FROM THE CORD, ALL FORCES WERE FOUND TO BE WITHIN CONFORMANCE PER THE STANDARD RECOMMENDEDATIONS FOR PULL FORCE. THE DEVICES FROM THE FACILITY WERE RETURNED AS WELL. THESE DEVICES WERE ALSO TESTED, AND FOUND TO BE WITHIN CONFORMANCE. THE FORCEPS WILL NOT FALL OUT ON THEIR OWN, HOWEVER IF THE CORD IS CAUGHT ON SOMETHING DURING USE AND THE FORCEPS ARE PULLED, IT CAN COME OUT OF THE FEMALE CONNECTOR OF THE CORD. THERE HAS BEEN A TOTAL OF (B)(4) FORCEP AND CORD COMBINATIONS SOLD, WITH NO ADDITIONAL COMPLAINTS RECORDED. THIS IS AN ISOLATED EVENT WITH NO FAULT FOUND IN EITHER THE FORCEPS OR THE CORD. WE WILL CONTINUE TO TRACK AND TREND FOR ANY FUTURE COMPLAINTS. THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ADDITIONAL PATIENT INVOLVEMENT OR INFORMATION PERTINENT TO THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT THE DISPOSABLE FORCEPS DO NOT SECURELY ATTACHED TO THE SUPPLIED BIPOLOAR CORD THAT COME WITH THE FORCEPS IN THE PACKAGE. THIS IS CONCERNING BECAUSE THE TIPS ARE SHARP AND THEY HAVE BEEN FALLING OFF INTRA OPERATIVELY. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928922 SYMMETRY OLSEN BIPOLAR FORCEPS GEI OLSEN MEDICAL 125387

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown