BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOROS SUPERSLIDE RETRACTOR

    MDR report key: 11036824 · Received December 17, 2020

    Report

    Report Number
    MW5098445
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 16, 2020
    Manufacturer
    KOROS USA, INC.
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MISSING RETAINING PIN FOR KOROS SUPERSLIDE RETRACTOR FRAME, PART NUMBER 7329-10M. THIS PART OF THE FRAME CONSISTS OF AN ARM CONNECTED BY A HINGE, A BAR WITH RATCHETS AND A RETAINING PIN ON THE NON-RATCHETED SIDE OF THE BAR, AND A TURNING KNOB. THESE COMPONENTS ARE NOT DESIGNED TO DISASSEMBLE. THE OTHER ARM FOR THE RETRACTOR FRAME DOES DISASSEMBLE VIA A THUMBSCREW. THE RATCHETED BAR IS DESIGNED WITH A RETAINING PIN THAT PREVENTS THE TURNING KNOB FROM COMPLETELY SLIDING OFF THE BAR. AFTER A SURGICAL PROCEDURE, THE RETRACTOR WAS RETURNED TO STERILE PROCESSING WITH THE TURNING KNOB COMPLETELY REMOVED FROM THE RATCHET BAR CAUSED BY THE RETAINING PIN BEING MISSING. THE TURNING KNOB HAS INTERNAL ALIGNMENT PINS THAT STAY IN PLACE AS LONG AS THE KNOB REMAINS ON THE BAR. BECAUSE THE KNOB SLID COMPLETELY OFF, THE ALIGNMENT PINS FELL OUT OF THEIR SLOTS. THE POINT AT WHICH THE RETAINING PIN WENT MISSING IS UNKNOWN. DEVICE REPORTED INTERNALLY AND TO MANUFACTURER. AFFECTED RETRACTOR AND 2 OTHER NON-AFFECTED RETRACTORS (SAME MODELS) PULLED FROM SERVICE. DURING FOLLOW UP PHONE CONVERSATION WITH MANUFACTURER, MANUFACTURER STATED THAT ULTRASONIC WASHING COULD HAVE LOOSENED THE PIN. THE INSTRUCTIONS FOR USE RECOMMEND SONICATION. MANUFACTURER WAS ASKED IF SONICATION SHOULD BE REMOVED FROM IFU OR NOT BE PERFORMED; MANUFACTURER RESPONDED THAT SONICATION SHOULD BE PERFORMED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498962 KOROS SUPERSLIDE RETRACTOR RETRACTOR GAD KOROS USA, INC. 7329-10M UNK

    Patients

    Seq Age Sex Outcome Treatment
    1