BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAST QUADRANT RETRACTOR SYSTEM

    MDR report key: 3836157 · Received May 28, 2014

    Report

    Report Number
    1030489-2014-02654
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    February 3, 2014
    Report Date
    February 4, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    FSZ
    PMA / PMN Number
    K043602
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL REVIEW OF THE INSTRUMENT IDENTIFIED ILLUMINATOR LIGHT SOURCE FITTING THAT APPEARED TO BE EXPOSED TO HIGH HEAT, AS EVIDENCE BY DISCOLORATION OF THE OPTICAL FIBERS AT THE FITTING AND MELTING OF BOTH THE EXTERNAL SHEATH AND INTERNAL OPTICAL FIBERS. THE DAMAGE IS CONSISTENT WITH EXCEEDING POWER LIMITS OF THE INSTRUMENT DURING USAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE SURGEON WAS BURNED THREE TIMES BY THE LIGHT SOURCE AND THEN THE LIGHT STOPPED FUNCTIONING. REPORTEDLY, THE BURNS WERE NOT SEVERE AND DID NOT MELT THE SURGEON¿S GLOVES OR LEAVE A MARK ON THE SKIN, BUT IT WAS MORE SHOCKING AND UNEXPECTED. THE INCIDENT ADDED TIME TO THE PROCEDURE AS THE SURGEON HAD TO REGAIN COMPOSURE EACH TIME. AFTER THE LIGHT STOPPED FUNCTIONING THERE WAS NO BACKUP SO THE SURGEON HAD TO RELY ON HIS HEAD LAMP AND OVERHEAD LIGHTS WHICH WASN¿T IDEAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312754 MAST QUADRANT RETRACTOR SYSTEM LIGHT, SURGICAL, CARRIER FSZ WARSAW ORTHOPEDICS NA 0274914W

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Other