BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RULTRACT SKYHOOK SURGICAL RETRACTOR SYSTEMS

    MDR report key: 4649850 · Received March 26, 2015

    Report

    Report Number
    1519227-2015-00001
    Event Type
    Malfunction
    Date Received
    March 26, 2015
    Report Date
    March 24, 2015
    Manufacturer
    PEMCO, INC.
    Product Code
    GAD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO AN OVERSIGHT, NO MDR WAS FILED AT THE ORIGINAL TIME WHEN THE DEVICE WAS RECEIVED. THIS DEVICE WAS PART OF A RECALL AND WAS NEVER RETURNED UNTIL AFTER THE RECALL HAD BEEN CLOSED.

    Description of Event or Problem · 1

    A REP FROM THE HOSP CONTACTED PEMCO AND STATED THAT BY THE FACILITY'S STANDARDS, A MALFUNCTION HAD OCCURRED. THE RATCHET CAME IN WITH A CUT CABLE. THIS DEVICE SERIAL NUMBER (B)(4) WAS PART OF A RECALL AND WAS NEVER RETURNED TO PEMCO AFTER THE RECALL HAD BEEN CLOSED. PER (B)(4) ' CONVERSATION WITH (B)(4), HE HAD STATED THAT THE CABLE WAS CUT BECAUSE THE RATCHET JAMMED DURING SURGERY AND THE RAKE PLATE COULD NOT BE REMOVED. THE ROOT CAUSE WAS A RECALLED PART THAT HAD MALFUNCTIONED. THE COVER PLATE WAS REPLACED AS PART OF THE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201820 RULTRACT SKYHOOK SURGICAL RETRACTOR SYSTEMS RATCHET ASSEMBLY WITH SNAP CLIP GAD PEMCO, INC. IR4100-IMR-41 NA

    Patients

    Seq Age Sex Outcome Treatment
    1