BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JARIT SUPERCUT ENDO SCISSORS, ROTO-CAM, MONOPOL

    MDR report key: 1235163 · Received July 9, 2008

    Report

    Report Number
    2430952-2008-00009
    Event Type
    Malfunction
    Date Received
    July 9, 2008
    Date of Event
    February 20, 2008
    Report Date
    June 5, 2008
    Manufacturer
    TONTARRA MEDIZINTECHNIK GMBH
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY SUBMITTED MEDICAL DEVICE REPORT STATING THAT LAPAROSCOPIC SURGERY WAS PERFORMED FOR LYSIS OF ADHESIONS WHEN A BLADE BROKE OFF OF THE JARIT SUPERCUT ENDO SCISSORS, ROTO-CAM MONOPOLAR. THE SURGEON AND STAFF WERE ABLE TO VISUALIZE THE BROKEN PIECE WITH THE LAPAROSCOPE. THE PROCEDURE WAS CONVERTED TO A LAPAROTOMY TO LOCATE THE ENDOSHEAR BLADE. THE BROKEN PIECE WAS RETRIEVED. INTEGRA LIFESCIENCES CORP RECEIVED ADDITIONAL INFO ON 05/14/08 FROM RISK MGMT. THE PHYSICIAN HAD USED THIS DEVICE AND BLADE NUMEROUS TIMES WITHOUT ANY INCIDENT AND WAS PROFICIENT IN THE USE OF THIS DEVICE. INTEGRA WAS ADVISED THAT THERE WAS NO INJURY TO THE PT. THE PART WAS RETRIEVED FROM THE PT'S ABDOMEN. AN X-RAY WAS DONE WHICH REVEALED THAT NOTHING WAS LEFT BEHIND. THERE WERE NO POST-OPERATIVE COMPLICATIONS AS A RESULT OF THIS INCIDENT, NOR WAS ANY OTHER MEDICAL TREATMENT NECESSARY AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JARIT SUPERCUT ENDO SCISSORS, ROTO-CAM, MONOPOL * GEI TONTARRA MEDIZINTECHNIK GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR