BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELUXE POSTERIOR VITRECTOMY PACK

    MDR report key: 102188 · Received June 27, 1997

    Report

    Report Number
    1119279-1997-00179
    Event Type
    Malfunction
    Date Received
    June 27, 1997
    Date of Event
    May 21, 1997
    Report Date
    June 3, 1997
    Manufacturer
    STORZ OPHTHALMICS, INC.
    Product Code
    KYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER STATED CASSETTE DID NOT FIR INTO THE MACHINE DURING SURGICAL SETUP. SURGERY WAS NOT IN PROGRESS AT THE TIME, HOWEVER, THERE WAS A HALF HOUR DELAY WHILE THEY ATTEMPTED TO REPLACE THE CASSETTE WITH ONE THAT WOULD WORK. THERE WAS NO ADVERSE EFFECT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELUXE POSTERIOR VITRECTOMY PACK SURGICAL ACCESSORY KYG STORZ OPHTHALMICS, INC. DP 4800 S0538

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other