BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY KARLIN

    MDR report key: 10512213 · Received September 9, 2020

    Report

    Report Number
    3007208013-2020-00025
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 11, 2020
    Report Date
    September 9, 2020
    Manufacturer
    SYMMETRY SURGICAL INC
    Product Code
    EMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE DISCARDED BY THE HOSPITAL. ADDITIONALLY, PICTURES WERE NOT ABLE TO BE PROVIDED. THE INSPECTION RECORDS AND MATERIAL CERTIFICATES WERE REVIEWED WITH ALL ITEMS FOUND TO BE WITHIN CONFORMANCE DURING MANUFACTURING AND INSPECTION. THERE HAS BEEN A TOTALLY OF (B)(4) BOXES OF 3 ((B)(4)) SOLD OF 46-3177 AND (B)(4) BOXES OF 3 ((B)(4)) SOLD OF 46-3178 SINCE 2012. THERE HAVE BEEN 2 ADDITIONAL COMPLAINTS RECORDED FOR 46-3177 SINCE 2012 BOTH OF WHICH WERE FOUND TO BE ATTRIBUTED TO EXCESSIVE FORCE. (B)(4). THERE HAVE BEEN 2 ADDITIONAL COMPLAINT RECORDED FOR 46-3178 SINCE 2012 BOTH WERE FOUND TO BE EXCESSIVE STRESS ON THE TIP. (B)(4). THE CUSTOMER WAS WARNED AGAINST USING ANY SIDEWAYS OR EXCESSIVE FORCE WHILE USING THE BLADES. BASED ON THE ABOVE INFORMATION, NO ADDITIONAL INFORMATION IS NECESSARY AND THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR NEEDED CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING THE PROCEDURE TWO BLADES BROKE AND FELL INTO THE PATIENT. THE TIPS WERE REMOVED WITH SUCTION WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970621 SYMMETRY KARLIN BLADE EMF SYMMETRY SURGICAL INC 19D1170, 18G1920

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention