BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KLI MEDICAL

    MDR report key: 98731 · Received June 11, 1997

    Report

    Report Number
    98731
    Event Type
    Malfunction
    Date Received
    June 11, 1997
    Date of Event
    April 18, 1997
    Report Date
    April 25, 1997
    Manufacturer
    CABOT MEDICAL CORP.
    Product Code
    KNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING TUBAL LIGATION SURGERY, FALOPE RING APPLICATOR MISFIRED AND LACERATED RIGHT TUBE. SECOND APPLICATOR USED AND ALSO MISFIRED AND LACERATED LEFT TUBE. RINGS APPLIED INCORRECTLY. LASER WAS THEN USED TO CUT TUBES AND COMPLETE PROCEDURE. NO FURTHER UNTOWARD EFFECTS TO PT. APPLICATOR PULLED FROM SERVICE FOR EVAL AND REPAIR IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLI MEDICAL Implant FALOPE RING APPLICATOR KNH CABOT MEDICAL CORP. 002094-504 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other