BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2442634 · Received January 20, 2012

    Report

    Report Number
    3007069406-2012-00017
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Report Date
    March 2, 2011
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2012: THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MFR. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE BENDABLE SECTION OF THE ADENOID TIP WAS SEPARATED FROM THE FINGER GRIP. THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO THE GLUE BOND BETWEEN THE TUBING AND FINGER GRIP, ALSO, THE BENDABLE TUBE HAS A GLOSSY FINISH WHICH MAY MAKE IT DIFFICULT TO PRODUCT A STRONG BOND BETWEEN THE FINGER GRIP AND BENDABLE TUBE. INVESTIGATION OF THE LOT HISTORY RECORD DID NOT NOTE ANY ISSUES DURING THE MFG. FAILURE INVESTIGATION CONFIRMED THE EVENT REPORTED AND THE ROOT CAUSE WAS ATTRIBUTED TO THE BOND JOINT BETWEEN THE TUBING AND FINGER GRIP. A CORRECTION ACTION REPORT HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS TYPE OF FAILURE MODE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP DETACHED DURING SURGERY AND FELL INSIDE THE PT'S MOUTH. NO INJURY TO PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI PEAK SURGICAL, INC. PLASMABLADE TNA 30209

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT AVAILABLE