BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPOINT

    MDR report key: 2845033 · Received November 7, 2012

    Report

    Report Number
    3008845715-2012-00006
    Event Type
    Other
    Date Received
    November 7, 2012
    Date of Event
    September 13, 2012
    Report Date
    November 6, 2012
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH
    Product Code
    HNN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS REQUESTED TO THE CUSTOMER, FOR EVALUATION. A BIOHAZARD KIT WAS SENT TO THE CUSTOMER ON (B)(4) 2012. A RECORD REVIEW OF THE REPORTED FINISHED GOODS LOT, M353020, WAS PERFORMED, NO NON-CONFORMING REPORTS WERE ISSUED FOR THIS PRODUCT OR RESPECTIVE COMPONENT. THE RISK ASSESSMENT FOR THE NON CONFORMANCE REPORTED COULD CAUSE A DELAY IN SURGICAL PROCEDURE. THERE IS A HIGH CHANCE THAT CURRENT CONTROLS WILL DETECT THE POTENTIAL CAUSE AND/OR SUBSEQUENT FAILURE MODE, THEREFORE, AN ACCEPTABLE RISK. AS OF THE DAY OF THIS REPORT, SAMPLES HAVE NOT BEEN RECEIVED AT OUR PREMISES. A FOLLOW-UP REPORT WILL BE ISSUED ONCE SAMPLES ARE RECEIVED AND EVALUATED. (B)(4).

    Description of Event or Problem · 1

    DURING A SUBRETINAL ASPIRATION PROCEDURE, THE CUSTOMER STATES THAT THE SILASTIC GEL WAS EXPELLED FROM THE CANULA AND REMAINED IN THE PATIENT'S EYE. INTERVENTION REQUIRED TO REMOVE THE GEL FROM THE PATIENT'S SUB RETINAL SPACE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPOINT SUBRETINAL FLUID CANNULA STRAIGHT 6MM HNN SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH 4021 M353020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NONE MADE AVAILABLE