BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIGUIDE FIBER OPTIC DIFFUSER

    MDR report key: 23346342 · Received October 21, 2025

    Report

    Report Number
    3010119152-2025-00015
    Event Type
    Injury
    Date Received
    October 21, 2025
    Report Date
    December 11, 2025
    Manufacturer
    PINNACLE BIOLOGICS INC
    Product Code
    MVG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE REQUESTED ON 16-OCT-2025 AND COMPLAINT SAMPLE WAS EVALUATED ON AN UNKNOWN DATE. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Additional Manufacturer Narrative · 0

    THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Description of Event or Problem · 0

    ORIGINAL STERILE FIBER BROKE [DEVICE BREAKAGE]. FIBER FAILURE [DEVICE FAILURE]. SMOKE AROUND 177S INTO TREATMENT, SO WE STOPPED THE LASER [DEVICE ISSUE]. EXCESSIVE HEATING OF THE DIFFUSER SECTION WHICH WAS DUE TO OVER BENDING OF THE FIBER DURING LASER TESTING [DEVICE USE ERROR]. CASE NARRATIVE: CASE NUMBER: (B)(4) IS A SPONTANEOUS REPORT RECEIVED FROM PHARMACIST VIA MEDICAL INFORMATION DEPARTMENT (ADVANZ PHARMA) (REFERENCE ID: (B)(4) ON 14-OCT-2025. THIS REPORT REFERS TO UNKNOWN AGE UNKNOWN GENDER PATIENT WHO HAD DEVICE BREAKAGE (BROKEN DIFFUSER), DEVICE ISSUE (SMOKE AROUND 177S INTO TREATMENT, SO WE STOPPED THE LASER) AND DEVICE FAILURE (FIBER FAILURE), DEVICE USE ERROR (EXCESSIVE HEATING OF THE DIFFUSER SECTION WHICH WAS DUE TO OVER BENDING OF THE FIBER DURING LASER TESTING) FOLLOWING TREATMENT WITH PHOTOFRIN (PORFIMER SODIUM). THE PATIENT'S MEDICAL HISTORY, HISTORICAL MEDICATIONS, CONCURRENT CONDITION, AND CONCOMITANT MEDICATION WERE NOT REPORTED. ON UNKNOWN DATE, THE PATIENT WAS STARTED ON PHOTOFRIN AT AN UNKNOWN DOSE FOR ESOPHAGEAL CANCER. IT WAS REPORTED THAT THE ORIGINAL STERILE FIBER HAD BROKEN (5 CM FIBER, PB250, BATCH NUMBER: DB23074, EXPIRY DATE: 2028-03-23) AND THE DOCTOR AR NOTICED SMOKE AROUND 177 SECONDS INTO TREATMENT, SO HE STOPPED THE LASER. HE WAS ABLE TO RETRIEVE THE BROKEN DIFFUSER FROM THE PATIENT. THE 2ND FIBER PB250, 5.0 CM FIBER WAS OPENED AND CALIBRATED SO THEY COULD FINISH TREATMENT (LOT NO: DB23074, EXPIRY DATE: 23-MAR-2028) AND IT CALIBRATED AT 89 PERCENT ON THE FIRST ATTEMPT. UPON FOLLOW UP, COMPLAINT SAMPLE REQUESTED ON 16-OCT-2025. PRODUCT VARIANT INCLUDED PORFIMER SODIUM POWDER FOR SOLUTION FOR INJECTION 75 MG / VIAL. SIMILAR COMPLAINTS RECEIVED FOR THE COMPLAINT BATCH: (DB23074): NONE. THE PROXIMAL END OF THE FIBER IS IN GOOD CONDITION. THE DIFFUSER SECTION WAS BURNED/CHARRED ON THE DISTAL END OF THE SILVER RING; THERE WAS ALSO A VISIBLE BENDING ON THE BURNED SECTION. THE POSSIBLE CAUSE FOR THAT FAILURE WAS EXCESSIVE HEATING OF THE DIFFUSER SECTION WHICH WAS DUE TO OVER BENDING OF THE FIBER DURING LASER TESTING. PQE: 049942 AND COMPLAINT NO: (B)(4). COMPLAINT STATUS WAS CLOSED AND DATE CLOSED WAS 28-NOV-2025. THE PATIENT'S TREATMENT MEDICATION AND LAB TEST WERE NOT REPORTED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE EVENT DEVICE ISSUE, DEVICE FAILURE, DEVICE USE ERROR AND DEVICE BREAKAGE WAS UNKNOWN ACTION TAKEN WITH PHOTOFRIN WAS NOT APPLICABLE. DE-CHALLENGE AND RECHALLENGE RESULTS WERE NOT APPLICABLE WITH RESPECT TO PHOTOFRIN. THIS CASE IS CONSIDERED TO BE SERIOUS DUE TO SERIOUSNESS CRITERIA INTERVENTION REQUIRED, OTHER MEDICALLY IMPORTANT CONDITION FOR EVENTS DEVICE BREAKAGE HOWEVER THE EVENT DEVICE ISSUE, DEVICE USE ERROR AND DEVICE FAILURE WAS NON-SERIOUS. THE REPORTER CONSIDERED THE EVENTS DEVICE ISSUE, DEVICE FAILURE AND DEVICE BREAKAGE AS UNLIKELY RELATED TO PHOTOFRIN AND POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER (DEVICE). HOWEVER, CONSIDERED THE EVENT DEVICE USE ERROR AS UNLIKELY RELATED TO PHOTOFRIN AND POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER (DEVICE). CONSENT TO FOLLOW UP WITH REPORTER WAS PROVIDED. FOLLOW UP INFORMATION WAS RECEIVED ON 01-DEC-2025. ADDITIONAL INFORMATION INCLUDED: CLOSED INVESTIGATION REPORT, EVENT (DEVICE USE ERROR) AND REFERENCE NUMBERS WERE ADDED. NARRATIVE AMENDED ACCORDINGLY. CASE COMMENTS: THE CASE IS ASSESSED AS SERIOUS AND LISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENTS DEVICE BREAKAGE, DEVICE ISSUE, DEVICE FAILURE AND DEVICE USE ERROR TO BE UNLIKELY RELATED TO PORFIMER SODIUM DRUG, AS PER WHO CAUSALITY CLASSIFICATION SYSTEM, AS EVENTS WERE REPORTED WITH DEVICE AND NOT DRUG. THE CASE IS ASSESSED AS SERIOUS AND LISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENTS OF DEVICE BREAKAGE, DEVICE ISSUE, DEVICE FAILURE AND DEVICE USE ERROR TO BE POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER DEVICE, AS PER CONVENTION.

    Description of Event or Problem · 0

    ORIGINAL STERILE FIBER BROKE [DEVICE BREAKAGE] FIBER FAILURE [DEVICE FAILURE] SMOKE AROUND 177S INTO TREATMENT, SO WE STOPPED THE LASER [DEVICE ISSUE]. CASE NARRATIVE: CASE NUMBER (B)(4) IS A SPONTANEOUS REPORT RECEIVED FROM PHARMACIST VIA MEDICAL INFORMATION DEPARTMENT (ADVANZ PHARMA) (REFERENCE ID: (B)(4)) ON (B)(6) 2025. THIS REPORT REFERS TO UNKNOWN AGE UNKNOWN GENDER PATIENT WHO HAD DEVICE BREAKAGE (BROKEN DIFFUSER), DEVICE ISSUE (SMOKE AROUND 177S INTO TREATMENT, SO WE STOPPED THE LASER) AND DEVICE FAILURE (FIBER FAILURE) FOLLOWING TREATMENT WITH PHOTOFRIN (PORFIMER SODIUM). THE PATIENT'S MEDICAL HISTORY, HISTORICAL MEDICATIONS, CONCURRENT CONDITION, AND CONCOMITANT MEDICATION WERE NOT REPORTED. ON UNKNOWN DATE, THE PATIENT WAS STARTED ON PHOTOFRIN AT AN UNKNOWN DOSE FOR ESOPHAGEAL CANCER. IT WAS REPORTED THAT THE ORIGINAL STERILE FIBER HAD BROKEN (5 CM FIBER, PB250, BATCH NUMBER: DB23074, EXPIRY DATE: 2028-03-23) AND THE DOCTOR AR NOTICED SMOKE AROUND 177 SECONDS INTO TREATMENT, SO HE STOPPED THE LASER. HE WAS ABLE TO RETRIEVE THE BROKEN DIFFUSER FROM THE PATIENT. THE 2ND FIBER PB250, 5.0 CM FIBER WAS OPENED AND CALIBRATED SO THEY COULD FINISH TREATMENT (LOT NO: DB23074, EXPIRY DATE: 23-MAR-2028) AND IT CALIBRATED AT 89 PERCENT ON THE FIRST ATTEMPT. THE PATIENT'S TREATMENT MEDICATION AND LAB TEST WERE NOT REPORTED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE EVENT DEVICE ISSUE, DEVICE FAILURE AND DEVICE BREAKAGE WAS UNKNOWN. ACTION TAKEN WITH PHOTOFRIN WAS NOT APPLICABLE. DE-CHALLENGE AND RECHALLENGE RESULTS WERE NOT APPLICABLE WITH RESPECT TO PHOTOFRIN. THIS CASE IS CONSIDERED TO BE SERIOUS DUE TO SERIOUSNESS CRITERIA INTERVENTION REQUIRED, OTHER MEDICALLY IMPORTANT CONDITION FOR EVENTS DEVICE BREAKAGE HOWEVER THE EVENT DEVICE ISSUE AND DEVICE FAILURE WAS NON-SERIOUS. THE REPORTER CONSIDERED THE EVENTS DEVICE ISSUE, DEVICE FAILURE AND DEVICE BREAKAGE AS UNLIKELY RELATED TO PHOTOFRIN AND POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER (DEVICE). CONSENT TO FOLLOW UP WITH REPORTER WAS PROVIDED. CASE COMMENTS: THE CASE IS ASSESSED AS SERIOUS AND LISTED AS PER THE COMPANY RSI. EVENTS DEVICE BREAKAGE, DEVICE ISSUE AND DEVICE FAILURE TO BE UNLIKELY RELATED TO PORFIMER SODIUM DRUG, AS PER WHO CAUSALITY CLASSIFICATION SYSTEM, AS EVENTS WERE REPORTED WITH DEVICE AND NOT DRUG. THE CASE IS ASSESSED AS SERIOUS AND LISTED AS PER THE COMPANY RSI. THE COMPANY CONSIDERED THE EVENTS OF DEVICE BREAKAGE, DEVICE ISSUE AND DEVICE FAILURE TO BE POSSIBLY RELATED TO OPTIGUIDE FIBER OPTIC DIFFUSER DEVICE, AS PER CONVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193825 OPTIGUIDE FIBER OPTIC DIFFUSER FIBER MVG 00376128000261 DB23074

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O