BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITE STAR HIGH SPEED VIT CUTTER

    MDR report key: 2832933 · Received November 15, 2012

    Report

    Report Number
    2020664-2012-00087
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION AND ANALYSIS OF THE DEVICE WAS NOT PERFORMED. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER OF THE SUSPECT MEDICAL DEVICE (VITRECTOMY CUTTER) #1 IS (B)(4). THE SERIAL NUMBER OF THE SUSPECT MEDICAL DEVICE (VITRECTOMY CUTTER) #2 IS (B)(4). VITRECTOMY CUTTER #1 AND #2 WERE EVALUATED BY THE MANUFACTURER. VITRECTOMY CUTTER #1 WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. ASPIRATION PATH WAS CLEAR. VITRECTOMY CUTTER #2 WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. ASPIRATION PATH WAS CLEAR. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER HAD AN ISSUE WITH PERFORMING A VITRECTOMY. CUSTOMER USED TWO WHITE STAR HIGH SPEED VITRECTOMY CUTTERS, BUT THEY DID NOT ASPIRATE. VACUUM WAS NOT CONSTANT AND ZERO SOMETIMES. BOTH CUTTERS WERE PROPERLY PRIMED AND THE CUTTER WAS MOVING ALL THE TIME. THE DOCTOR MANAGED TO REMOVE THE VITREOUS OUT OF THE WOUND MANUALLY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITE STAR HIGH SPEED VIT CUTTER PHACO ACCESSORY HQC ABBOTT MEDICAL OPTICS NGP0020

    Patients

    Seq Age Sex Outcome Treatment
    1