BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVUITY, INC

    MDR report key: 6490282 · Received April 13, 2017

    Report

    Report Number
    3011394215-2017-00001
    Event Type
    Malfunction
    Date Received
    April 13, 2017
    Date of Event
    January 26, 2017
    Report Date
    February 8, 2017
    Manufacturer
    INVUITY, INC
    Product Code
    FST
    UDI-DI
    00816728020226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POST INSPECTION, IT WAS OBSERVED ALL FOUR (4) CABLES EXHIBITED BROKEN FIBERS THROUGHOUT THE CABLE. ONE (1) OF THE FOUR (4) RETURNED CABLES EXHIBITED A CONCENTRATED NUMBER OF BROKEN FIBERS AT THE BIFURCATION WHICH INDICATES MISHANDLING AND ABUSE OF THE CABLE. THE CONCENTRATION OF BROKEN FIBERS LED TO AN ELEVATED TEMPERATURE AT THE BIFURCATION OF 64.0 C. INVUITY'S IFU CLEARLY STATES TO HANDLE THE CABLES WITH CARE AND NOT TO COIL THE CABLES TIGHTER THAN SIX (6) INCHES.

    Description of Event or Problem · 1

    IN A POST SURGERY FOLLOW UP, IT WAS OBSERVED THAT THE PATIENT HAD A FIRST DEGREE BURN ON THE CHEST. NO HOSPITALIZATION OR FURTHER TREATMENT WAS REQUIRED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271942 INVUITY, INC BIFURCATED FIBER OPTIC CABLE, 11.5FT FST INVUITY, INC FC1B UNKNOWN 00816728020226

    Patients

    Seq Age Sex Outcome Treatment
    1 EIKON LT| LUXTEC MLX| PHOTONGUIDE, NARROW/FLAT| PHOTONGUIDE, WIDE/FLAT| PHOTONSABER Y