BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIGUIDE FIBER OPTIC DIFFUSER

    MDR report key: 9496404 · Received December 19, 2019

    Report

    Report Number
    3010119152-2019-00003
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Date of Event
    November 25, 2019
    Report Date
    January 31, 2020
    Manufacturer
    PINNACLE BIOLOGICS, INC.
    Product Code
    MVG
    UDI-DI
    00376128000261
    PMA / PMN Number
    P940010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULT CODES HAVE BEEN GENERATED DUE TO THE UNDUE STRESS THE DIFFUSER SUFFERED DURING THE PROCEDURE. THE INSTRUCTION IN THAT COME WITH EACH FIBER STATE " FRAGILE: CONTAIN GLASS FIBER THAT MAY BREAK IF HANDLED ROUGHLY OR BENT SHARPLY. DO NOT CLAMP THE FIBER DIRECTLY. STORE IN A COOL DRY PLACE." THE CONCLUSION FROM THE MANUFACTURES INVESTIGATING IS IN LINE WITH THESE INSTRUCTION NOT BEING FOLLOWED.

    Description of Event or Problem · 0

    THE PATIENT WAS BEING TREATED FOR ESOPHAGEAL CANCER. THE LIGHT APPLICATION WENT WITHOUT INCIDENT. THE FIBER WAS REMOVED FROM THE SCOPE. WHEN THE SCOPE WAS REMOVED FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE FIBER TIP HAD BECOME DISCONNECTED AND WAS FOUND IN THE TIP OF THE ENDOSCOPE. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE PRODUCT LABELING. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION. FOLLOW-UP #1 A COMPLAINT ANALYSIS AND RESPONSE WAS RECEIVED FROM THE VENDOR ON 07-JAN-2020. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE VENDOR ANALYSIS STATED THAT THE PROXIMAL END OF THE OPTIGUIDE FIBER OPTIC DIFFUSER WAS IN GOOD CONDITION. THE DISTAL END WAS BROKEN WITH THICK CARBONIZED TISSUE/FLUID SURROUNDING THE PROXIMAL END OF THE DIFFUSER TIP. APPROXIMATELY 2 ½ MM OF THE FIBER WAS PROTRUDING FROM THE BROKEN END OF THE DIFFUSER CAPSULE. PER VENDOR, IT IS SPECULATED ON THE EVIDENCE SEEN FROM THE 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 FIBER. THE FORCE, EITHER FROM ENTERING OR RE-ENTERING THE ENDOSCOPE, OR THE FIBER BEING PUSHED AGAINST THE ESOPHAGEAL TISSUE/TUMOR CAUSED UNDUE STRESS TO THE FIBER, HOUSING, AND EPOXY UNION. 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. SINCE THE FIBER TIP WAS STILL INTACT IT IS REASONED THAT THE TREATMENT WAS SUCCESSFULLY CONCLUDED. THIS CASE CORRESPONDS TO THE FOLLOWING PINNACLE BIOLOGICS INC. ICSR#: (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TREATED FOR ESOPHAGEAL CANCER. THE LIGHT APPLICATION WENT WITHOUT INCIDENT. THE FIBER WAS REMOVED FROM THE SCOPE. WHEN THE SCOPE WAS REMOVED FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE FIBER TIP HAD BECOME DISCONNECTED AND WAS FOUND IN THE TIP OF THE ENDOSCOPE. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE PRODUCT LABELING. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION. THIS CASE CORRESPONDS TO THE FOLLOWING PINNACLE BIOLOGICS INC. ICSR#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290357 OPTIGUIDE FIBER OPTIC DIFFUSER FIBER OPTIC DIFFUSER MVG PINNACLE BIOLOGICS, INC. PB200 DG19048 00376128000261

    Patients

    Seq Age Sex Outcome Treatment
    1 630 PDT LASER| 630 PDT LASER