BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ NEIVERT-EVE TONSIL SNARE

    MDR report key: 108630 · Received July 24, 1997

    Report

    Report Number
    1932180-1997-00063
    Event Type
    Malfunction
    Date Received
    July 24, 1997
    Date of Event
    June 26, 1997
    Report Date
    June 26, 1997
    Manufacturer
    STORZ INSTRUMENT CO.
    Product Code
    KBZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SALES REPRESENTATIVE VISTIED THE ACCOUNT AND INDICATED THAT UNFAMILIARITY WITH THIS PRODUCT WAS MOST PROBALBY THE CAUSE FOR THE PROBLEMS EXPERIENCED. THIS ACCOUNT WAS USED TO USING ANOTHER TYPE OF SNARE. THE REPRESENTATIVE EXPLAINED HOW THIS TONSIL SNARE WORKS AND MADE SOME SUGGESTIONS TO THEM ON WIRE USAGE THAT SHOULD SOLVE THEIR PROBLEMS. THIS TONSIL SNARE IS WORKING PROPERLY; THERE ARE NO DEFECTS WITH THE SNARE.

    Description of Event or Problem · 1

    DURING A TONSILLECTOMY PROCEDURE, THE DOCTOR PUT THE SNARE ON THE TONSIL THE SNARE WIRE GOT STUCK. THE TONSIL HAD TO BE CUT OUT AROUND THE SNARE WIRE SO THAT IT COULD BE REMOVED. THE PT DID NOT SUFFER ANY ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ NEIVERT-EVE TONSIL SNARE TONSIL SNARE KBZ STORZ INSTRUMENT CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention