BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN SURGICAL PRODUCTS

    MDR report key: 326701 · Received April 13, 2001

    Report

    Report Number
    326701
    Event Type
    Malfunction
    Date Received
    April 13, 2001
    Date of Event
    March 19, 2001
    Report Date
    April 6, 2001
    Manufacturer
    ASPEN SURGICAL PRODUCTS
    Product Code
    KBZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    END OF 7 GAUGE TONSIL SNARE (X2) BROKE OFF DURING PROCEDURE (TONSILLECTOMY). SURGEON IRRIGATED AND SUCTIONED COPIOUSLY AND X-RAY X3. TONSILS X-RAYED ALSO POST-PROCEDURE. SNARE WAS NOT FOUND. SNARE PROBABLY RETAINED WITHIN INSTRUMENT (SNARE GUN). 8 GAUGE TONSIL SNARE WAS USED FOR PROCEDURE. PACKAGING OF DIFFERENT SIZE TONSIL SNARES SIMILAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17293 ASPEN SURGICAL PRODUCTS TONSIL SNARE KBZ ASPEN SURGICAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other