BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE PACK, DISPOSABLE TUBING

    MDR report key: 2924741 · Received January 22, 2013

    Report

    Report Number
    2020664-2013-00004
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 21, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. EXPIRATION DATE: UNKNOWN AS THE SERIAL NUMBER IS UNKNOWN. IS THIS A SINGLE USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT: NO. DEVICE AVAILABLE FOR EVALUATION: NO. (B)(4). MANUFACTURE DATE: UNKNOWN AS THE SERIAL NUMBER IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN EVALUATED AS IT HAS NOT BEEN RETURNED. NO INFORMATION REGARDING THE PATIENT OR ANY PATIENT IDENTIFIER HAS BEEN PROVIDED. NO LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. THEREFORE, NO MANUFACTURING RECORD CAN BE REVIEWED. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WITH OPO71 CASSETTE ATTACHED TO SIGNATURE SYSTEM, THE PHYSICIAN SWITCHED THE MODE FROM PERISTALTIC TO VENTURI DURING OPERATION; THE HEIGHT OF BOTTLE WAS ALSO CHANGED FROM 65 CM FOR PERISTALTIC TO 80 CM FOR VENTURI BOTTLE. WHEN HE EXTENDED THE POLE, THE DRIP CHAMBER SPIKE FELL FROM BSS. AS A RESULT, LACK OF IRRIGATION CAUSED ANTERIOR CHAMBER COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29145 SIGNATURE PACK, DISPOSABLE TUBING PHACO TUBING HQC ABBOTT MEDICAL OPTICS OPO71

    Patients

    Seq Age Sex Outcome Treatment
    1 Other