BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYO/PUNCH ROTATING SURGICAL PUNCH

    MDR report key: 3560633 · Received November 1, 2013

    Report

    Report Number
    2242056-2013-00001
    Event Type
    Malfunction
    Date Received
    November 1, 2013
    Date of Event
    January 1, 2013
    Report Date
    October 30, 2013
    Manufacturer
    ALTO DEVELOPMENT CORP
    Product Code
    LRY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY, SURGICAL PUNCH, 080-402: THE ACTUAL PUNCH USED IN THE PROCEDURE WAS EVALUATED. ALTHOUGH SOILED FROM OPERATING ROOM USE, THERE WERE NO APPARENT SURFACE DEFECTS. THE CUTTING SURFACES APPEARED SHARP AND SMOOTH UNDER 10X MAGNIFICATION. THE SUSPECT PUNCH DEPRESSED, FULLY ROTATED AND RETURNED TO STARTING POSITION MULTIPLE TIMES. NO INTERFERENCE BETWEEN THE CUTTING COMPONENTS WAS NOTED. ALL ACTIVATION MOTIONS WERE SMOOTH AND EVEN. THE SUSPECT PUNCH WAS TESTED FOR SHARPNESS AND QUALITY OF CUT BY CREATING HOLES IN TEST MEDIA AND INSPECTING THESE HOLES UNDER 10X MAGNIFICATION. NORMAL EFFORT WAS REQUIRED TO COMPLETE THESE CUTS. THE HOLES CREATED IN TEST MEDIA WITH THE SUSPECT PUNCH WERE SHARP AND CLEAN. THERE WERE NO FIBERS OR RAGGED EDGES PRESENT. THE SHARPNESS AND QUALITY OF EACH HOLE FORMED BY THE RETURNED PUNCH MET SPECIFICATIONS. THE RETURNED PUNCH MET ALL FUNCTIONAL REQUIREMENTS. THE RESULTS OF OUR VISUAL EXAMINATION AND PHYSICAL TESTING OF THE SUSPECT PUNCH DID NOT CONFIRM THE "DID NOT MAKE A CUT" CONDITION REPORTED BY THE COMPLAINANT. INITIAL REPORTER'S REPORT # 1423395-2013-0013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE AORTIC PUNCH DID NOT MAKE A CUT WHEN SURGEON WAS ATTEMPTING TO MAKE THE CORONARY ANASTOMOSIS ENTRY POINT." IT WAS ALSO REPORTED THAT "NO TEAR RESULTED AND THERE WAS NO INJURY TO PATIENT." NO ADVERSE EFFECTS TO USER TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564568 MYO/PUNCH ROTATING SURGICAL PUNCH PUNCH, SURGICAL LRY ALTO DEVELOPMENT CORP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other