BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEARL 8.0 HANDPIECE

    MDR report key: 3881474 · Received June 18, 2014

    Report

    Report Number
    2950727-2014-00012
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    INITIAL INFORMATION INDICATES THE CRYOLIFE REPRESENTATIVE HAD A PEARL 8.0 DEMO HANDPIECE THAT FELL APART AT THE TIP. THE HANDPIECE WAS NOT USED IN A PATIENT. THE HANDPIECE WAS RETURNED AND VISUALLY INSPECTED. THE DISTAL TIP WAS FOUND TO BE DISCONNECTED FROM THE SHAFT OF THE HANDPIECE. A KINK WAS NOTED ON THE DISTAL TIP. IT APPEARED TO BE LOCATED WHERE THE TIP WOULD CONNECT TO THE GUIDESHAFT, REPRESENTING AN AREA WHERE THE TIP MAY HAVE BENT; HOWEVER, IT DID NOT LINE UP EXACTLY WITH THE EDGE OF THE GUIDESHAFT WHEN THE TIP WAS PLACED BACK ON THE SHAFT. THE INSIDE OF THE DISTAL TIP WAS THEN EXAMINED TO SEE IF THERE WAS EVIDENCE OF WHY THE TIP WOULD HAVE SEPARATED FROM THE GUIDESHAFT. ADHESIVE COULD BE SEEN INSIDE OF THE TIP. THE HANDPIECE WAS FURTHER DISMANTLED TO EXAMINE THE STAINLESS STEEL ROD PORTION OF THE GUIDESHAFT. ADHESIVE WAS SEEN ON THE STEEL; IT APPEARED TO HAVE DRIPPED DOWN THE ROD PAST THE POINT WHERE THE DISTAL TIP WOULD BE CONNECTED. RESIDUAL ADHESIVE WAS ALSO SEEN INSIDE THE GUIDESHAFT. IT WAS UNCERTAIN IF THERE WAS A MANUFACTURING ISSUE OR IF THE DAMAGE OCCURRED DUE TO HANDLING AND STORAGE CONDITIONS OF THE DEMO HANDPIECE. AS A ROOT CAUSE OF THE BROKEN HANDPIECE AND DISCONNECTED DISTAL TIP COULD NOT BE DETERMINED, THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. RECORDS WERE REVIEWED AND ALL APPROVED HANDPIECES WENT THROUGH FINAL TESTING AND QUALITY INSPECTIONS. THE PEARL-8.0 HANDPIECE PRODUCT LINE HAS SINCE BEEN DISCONTINUED.

    Description of Event or Problem · 1

    INITIAL INFORMATION INDICATES THE CRYOLIFE REPRESENTATIVE HAD A PEARL 8.0 DEMO HANDPIECE THAT FELL APART AT THE TIP. THE HANDPIECE WAS NOT USED IN A PATIENT.

    Description of Event or Problem · 1

    INITIAL INFORMATION INDICATES THE CRYOLIFE REPRESENTATIVE HAD A PEARL 8.0 DEMO HANDPIECE THAT FELL APART AT THE TIP. THE HANDPIECE WAS NOT USED IN A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358019 PEARL 8.0 HANDPIECE TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE MNO CARDIOGENESIS CORPORATION HP-PRL8

    Patients

    Seq Age Sex Outcome Treatment
    1