BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIGUIDE FIBER OPTIC DIFFUSER

    MDR report key: 9769529 · Received February 28, 2020

    Report

    Report Number
    3010119152-2020-00001
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Date of Event
    January 28, 2020
    Report Date
    February 28, 2020
    Manufacturer
    PINNACLE BIOLOGICS, INC.
    Product Code
    MVG
    PMA / PMN Number
    P940010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS RECEIVING PDT TO TREAT A 10 CM LESION FROM ESOPHAGEAL CANCER. TWO PB250 RIGID FIBERS WERE USED. DURING THE FIRST LIGHT APPLICATION, THE FIRST FIBER WAS USED, FORCE WAS APPLIED BY THE PHYSICIAN, AND THE FIBER BROKE. THE FIBER AND SEVERED TIP WERE REMOVED. THE PHYSICIAN USED A SECOND FIBER, FORCE WAS APPLIED, AND THE FIBER BROKE AGAIN. THE PHYSICIAN SPECULATED SHORTLY AFTERWARDS THAT THERE COULD POSSIBLY BE A SCOPE/FIBER ISSUE THAT MAY HAVE CONTRIBUTED TO THE FORCE APPLIED TO THE FIBER, RESULTING IN BREAKAGE OF THE TIP. THE FIBERS WERE COLLECTED AND SENT TO THE VENDOR FOR FURTHER ANALYSIS AND INVESTIGATION. THE VENDOR ANALYSIS STATED THAT THE PROXIMAL CONNECTOR ENDS OF THE 2 PB250 RIGID FIBERS WERE IN GOOD CONDITION. THE DISTAL ENDS WERE BROKEN WITH CARBONIZED TISSUE/FLUID SURROUNDING THE PROXIMAL END OF ONE DIFFUSER TIP. APPROXIMATELY 2 ½ MM OF FIBER WAS PROTRUDING FROM THE BROKEN END OF BOTH DIFFUSER CAPSULES. PER VENDOR, IT WAS CONSIDERED, BASED ON THE EVIDENCE SEEN FROM EACH FIBER SAMPLE, AND DESCRIPTION OF EVENTS FROM THE COMPLAINT, THAT DURING THE PROCEDURE THERE WAS SOME UNEXPECTED SOURCE OF STRESS APPLIED TO THE DISTAL CAPSULE END OF THE FIBERS. THE FORCE, EITHER FROM INSERTION, OR WITHDRAWAL FROM THE ENDOSCOPE CAUSED UNDUE STRESS TO THE FIBER, HOUSING, AND EPOXY UNIONS. THE STRAIN LIKELY CAUSED A STRESS FLAW AT THE FIBER CAPSULE JUNCTION ALLOWING BODILY FLUIDS TO ENTER THE HOUSING, WITH THE PRESENT BODILY FLUID BEING HEATED FROM THE LASER ENERGY WITH THE RESULTING FLUID CARBONIZATION EXACERBATING THE FLAW CAUSING FULL FRACTURE OF THE CAPSULE. THIS CASE CORRESPONDS TO THE FOLLOWING PINNACLE BIOLOGICS INC. ICSR#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233135 OPTIGUIDE FIBER OPTIC DIFFUSER FIBER OPTIC DIFFUSER MVG PINNACLE BIOLOGICS, INC. PB250 DG19048

    Patients

    Seq Age Sex Outcome Treatment
    1 Other