BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRIGATION/ASPIRATION TIP, 90 DEGREE

    MDR report key: 41094 · Received September 23, 1996

    Report

    Report Number
    1920664-1996-00655
    Event Type
    Injury
    Date Received
    September 23, 1996
    Date of Event
    August 21, 1996
    Report Date
    August 26, 1996
    Manufacturer
    STORZ INSTRUMENT CO.
    Product Code
    HQE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THESE THREE TIPS HAVE VERY, VERY ROUGH ENDS WHICH CAN BE SEEN WHEN LOOKING AT THEM UNDER A MICROSCOPE. ALL OF THESE TIPS HAVE BEEN USED DURING PROCEDURES. ONE OF THESE TIPS WAS USED IN A PROCEDURE WHERE THE PHYSICIAN BROKE THE PT'S CAPSULE, BUT IT IS NOT KNOWN IF THIS TIP CAUSED THE BROKEN CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRRIGATION/ASPIRATION TIP, 90 DEGREE IRRIGATION/ASPIRATION TIP HQE STORZ INSTRUMENT CO. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention