BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFECTCUT AORTOTOMY SYSTEM, 4.5 MM

    MDR report key: 2595629 · Received May 30, 2012

    Report

    Report Number
    1649914-2012-00010
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    May 3, 2012
    Report Date
    May 3, 2012
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INSPECTION OF THE SAMPLE FOUND THAT THE STAINLESS STEEL CUTTING EDGE OF THE PUNCH WAS MARRED IN AREAS. THE ROOT CAUSE COULD NOT BE IDENTIFIED, BUT QUEST MEDICAL, INC HAS NOTIFIED THE COMPONENT SUPPLIER, WHO IS IMPLEMENTING CORRECTIVE ACTIONS. QUEST MEDICAL, INC HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THREE AORTIC PUNCHES (SAME LOT) EXPERIENCED A DEVICE MALFUNCTION DURING A PROCEDURE. ALLEGEDLY THE PUNCHES WOULD NOT DISENGAGE AS INTENDED DURING USE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT. ONE OF THE PUNCHES WAS RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFECTCUT AORTOTOMY SYSTEM, 4.5 MM CARDIOVASCULAR SURGICAL INSTRUMENT DWS QUEST MEDICAL, INC. RCK45 0414252J14

    Patients

    Seq Age Sex Outcome Treatment
    1