BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSV25 LIGHT PIPE

    MDR report key: 2581181 · Received August 2, 2010

    Report

    Report Number
    2529392-2010-00002
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    May 5, 2005
    Report Date
    July 22, 2010
    Manufacturer
    PEREGRINE SURGICAL LTD.
    Product Code
    MPA
    PMA / PMN Number
    K980797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR INDICATED THAT VISUAL INSPECTION OF THE LIGHT PIPE FOUND THAT NEEDLE TIP BROKEN NEAR THE BASE JUST ABOVE THE WELDED LOCATION. THE PIECE THAT REMAINED ATTACHED TO THE HANDPIECE HAD A CREASED AREA INDICATING THE NEEDLE TIP WAS BENT. THE EDGE OF THE METAL THAT REMAINED AFTER THE TIP BROKE AWAY LEFT A RIDGE OR JAGGED LIP PROTRUDING. THE BROKEN PIECE WAS ALSO FOUND TO BE BENT WITH A JAGGED LIP PROTRUDING FROM THE EDGE OF THE END THAT BROKE OFF.

    Description of Event or Problem · 1

    THE TIP OF THE LIGHT PIPE BROKE OFF IN THE PT'S EYE CAUSING A HEMATOMA ON THE MACULA. THE PT'S STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSV25 LIGHT PIPE 25GA LIGHT PIPE MPA PEREGRINE SURGICAL LTD. 04262725

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention