BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL CONSOLE WITH FOOTSWITCH EACH1

    MDR report key: 4613328 · Received March 13, 2015

    Report

    Report Number
    3006697299-2015-00031
    Event Type
    Malfunction
    Date Received
    March 13, 2015
    Date of Event
    February 18, 2015
    Report Date
    February 18, 2015
    Manufacturer
    INTEGRA LIFESCIENCES (IRELAND) LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(6) 2016. THE CUSA EXCEL CONSOLE WAS NOT RETURNED TO INTEGRA FOR THE COMPLAINT EVALUATION. THE DISTRIBUTOR COMMUNICATED TO INTEGRA PERSONNEL INCIDENTS OF THE CUSA EXCEL PINCH VALVE DOES NOT TOTALLY PINCH THE SUCTION TUBE WHEN THE FOOTSWITCH IS NOT ACTIVATED IN ¿LAP MODE¿. THE COMPLAINT EVALUATION WAS EVALUATED BY ILS TULLAMORE ENGINEERING. THE EVALUATION CONCLUDED THE TUBING WAS NOT CONCENTRIC THUS CAUSING THE COMPLAINT ISSUE AS REPORTED BY THE CUSTOMER. THE DHR REVIEW COULD NOT BE COMPLETED FOR THE COMPLAINT INCIDENT SINCE THE SERIAL NUMBER WAS NOT PROVIDED BY THE REPORTER FOR THE CUSA EXCEL CONSOLE. THE COMPLAINT DESCRIPTION REPORTS THERE WAS AN INCIDENT DURING THE LAP MODE FUNCTION OF THE CUSA EXCEL CONSOLE RESULTING IN THE PINCH VALVE NOT TOTALLY PINCHING THE SUCTION TUBE. THEREFORE A REVIEW OF CUSA EXCEL COMPLAINTS WAS COMPLETED IN COMPLAINT SYSTEM USING THE FOLLOWING KEY WORDS ¿LAP MODE¿ AND ¿PINCH VALVE¿ AND IN THE SEARCH CRITERIA. THE REVIEW ENCOMPASSED FROM DATES (B)(6) 2014 TO (B)(6) 2015. A TOTAL OF (B)(6) COMPLAINTS WERE REVIEWED OF WHICH ONLY THIS COMPLAINT CONTAINED THE SEARCH CRITERIA. RATE OF OCCURRENCE: DURING THE TIME PERIOD ¿(B)(6) 2014 TO (B)(6) 2015¿, THE GLOBAL PRODUCT USAGE FOR CUSA EXCEL CONSOLE WAS CALCULATED AS 103, 026 USAGES, USING THE TOTAL QUANTITY OF CUSA EXCEL CONSOLE TUBING SALES SOLD TO CALCULATE THE QUANTITY OF USAGES. ONE TUBING SET IS USED PER OPERATION / PROCEDURE, AND IS USED AS A MEANS OF QUANTIFYING THE NUMBER OF PROCEDURES UNDERTAKEN. THE QUANTITY OF COMPLAINTS WITH THE KEY WORDS IDENTIFIED IN THE COMPLAINT REVIEW CAN THEREFORE BE CALCULATED AS 0.0009% OF PROCEDURES. THE ROOT CAUSE OF THE COMPLAINT INCIDENT WAS VERIFIED AS THE SUCTION TUBING WAS NOT CONCENTRIC THUS CAUSING THE COMPLAINT ISSUE.

    Description of Event or Problem · 1

    DURING A MEETING BETWEEN THE DISTRIBUTOR AND INTEGRA, THE DISTRIBUTOR REPORTED THAT THERE WAS A RECURRENT PROBLEM WITH THE LAP MODE ON THE CUSA CONSOLES. THE PINCH VALVE DOES NOT TOTALLY PINCH THE SUCTION TUBE WHEN THE FOOTSWITCH WAS NOT ACTIVATED IN "LAP MODE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174716 EXCEL CONSOLE WITH FOOTSWITCH EACH1 NONE LFL INTEGRA LIFESCIENCES (IRELAND) LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1