BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUSA EXCEL 36KHZ STRAIGHT HANDPIECE

    MDR report key: 2473904 · Received February 28, 2012

    Report

    Report Number
    3006697299-2012-00013
    Event Type
    Death
    Date Received
    February 28, 2012
    Date of Event
    January 20, 2012
    Report Date
    February 28, 2012
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND LIMITED
    Product Code
    LFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION BY THE CUSTOMER. HOWEVER, AN INTEGRA SERVICE FIELD TECHNICIAN WILL BE CONDUCTING THE EVAL ON SITE AT THE USER FACILITY. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS INVOLVING THE SAME PT DURING THE SAME SURGERY. THIS IS IN REGARDS TO THE CUSA EXCEL 36KHZ STRAIGHT HANDPIECE USED. IT WAS INITIALLY REPORTED THAT THE PT HAD A "BAD OUTCOME. PT BLED OUT AFTER ARTERY WAS NICKED. THE PHYSICIAN WANTED THE CUSA SYSTEM CHECKED OUT BEFORE THEY USE IT AGAIN." ADD'L INFO WAS OBTAINED FROM THE CUSTOMER ON (B)(6) 2012, WITH THE FOLLOWING: A (B)(6) MALE PT WITH AN UNDERLYING MEDICAL CONDITION OF A LARGE PITUITARY TUMOR UNDERWENT A CRANIOTOMY ON (B)(6) 2012. IT WAS REPORTED THAT THE CUSA SYSTEM WAS BEING USED ON AND OFF DURING THE PROCEDURE. THE CLINICAL COORDINATOR WENT INSIDE THE OPERATING ROOM (OR) SUITE AND THE SURGEON STATED THAT THE HANDPIECE WAS NOT WORKING RIGHT, THAT IT WAS NOT STRONG ENOUGH. THE CLINICAL COORDINATOR STATED THAT THE NURSES IN THE OPERATING ROOM DID NOT THINK THAT THE SURGEON WAS COMPLAINING ABOUT THE CUSA SYSTEM WHEN THE SURGEON WOULD HAVE THE NURSE CHANGE THE POWER SETTING. THE CLINICAL COORDINATOR LOOKED INTO THE SURGEON'S COMPLAINT AND CHANGED THE SETTING TO SEE IF IT WAS WORKING OR NOT. THE SURGEON CONTINUED TO USE THE CUSA SYSTEM. THIRTY MINUTES FROM THE TIME THE CLINICAL COORDINATOR WAS MADE AWARE OF THE COMPLAINT BY THE SURGEON, THE SURGEON AGAIN STATED THAT THE HANDPIECE WAS NOT WORKING AS IT SHOULD. THE CLINICAL COORDINATOR CHANGED THE TISSUE SELECT SETTING ON THE CUSA EXCEL CONSOLE AND A CHANGE IN THE SOUND OF THE CONSOLE COULD BE HEARD AFTER THIS SELECTION. AFTERWARDS, THE CLINICAL COORDINATOR LOOKED AT THE SURGICAL SITE THROUGH THE MICROSCOPE AND NOTICED THAT THERE WAS BLOOD EVERYWHERE COMING FROM A VESSEL. THE CLINICAL COORDINATOR ALSO STATED THAT THE SURGEON WAS AWARE WHEN THE TISSUE SELECT SETTING WAS BEING CHANGED ON THE CUSA EXCEL CONSOLE. THE CLINICAL COORDINATOR ALSO STATED THAT THE OPERATION OF THE HANDPIECE WAS CONTROLLED BY THE SURGEON VIA THE FOOTSWITCH. TO CONTROL THE BLEEDING, AVITENE, TOPICAL AGENTS, GELFOAM, MANUAL PRESSURE, ETC., WERE USED. AFTER ABOUT 10-15 MINUTES, THE BLEEDING WAS CONTROLLED. SURGERY WAS COMPLETED ON (B)(6) 2012. THE PT REMAINED INTUBATED. FROM THE TIME THE SURGERY WAS COMPLETED ON (B)(6) 2012 TO (B)(6) 2012, THE PT HAD A STROKE (TYPE UNK). THE PT WAS NEVER EXTUBATED. ON (B)(6) 2012, THE PT WAS TAKEN OFF LIFE SUPPORT. DATE OF DEATH WAS REPORTED AS (B)(6) 2012. THE CAUSE OF DEATH WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSA EXCEL 36KHZ STRAIGHT HANDPIECE ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES (IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death