BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24630934 · Received March 18, 2026

    Report

    Report Number
    2955842-2026-16589
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    August 8, 2024
    Report Date
    March 18, 2026
    Manufacturer
    SCHOELLY FIBEROPTIC GMBH
    Product Code
    GCJ
    PMA / PMN Number
    K221591
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. FSE WORKED WITH THE CUSTOMER AND DISCOVERED THAT THE LIGHT SOURCE WAS NOT PROPERLY TURNED OFF WHEN THE NURSE HAD DISCONNECTED THE LIGHT GUIDE AND PLACED IT IN THE PLASTIC POCKET USED TO HOLD THE FIRST ENTRY CAMERA AND LIGHT GUIDE. THE NURSE HAD MISTAKEN THE OFF MODE FOR AN ACTIVATE MODE BEING THE NIR FI CONTRAST MODE WHERE THE TOWER MONITOR DISPLAYED A LASER SYMBOL WITH A BLACK AND WHITE DIAMOND ON THE UPPER RIGHT CORNER. SINCE THE MODE WAS ACTIVE, THE DISTAL END OF THE LIGHTGUIDE (PROXIMAL END CONNECTED FROM THE LIGHT SOURCE) WAS A CHERRY RED COLOR AND PRODUCED HEAT. THE NURSE PLACED THIS END IN THE PLASTIC WHICH CAUSED IT TO SMOKE AND BURN THE PLASTIC. PRESENT DURING THE INSPECTION WERE OR MANAGER, ROBOTIC COORDINATOR, AND BIOMED WERE PRESENT TO VERIFY THE INCORRECT SETUP AND TO REPLICATE THE ISSUE. CUSTOMER MENTIONED THAT HE WOULD PROVIDE ADDITIONAL IN-SERVICE TRAINING OPPORTUNITIES TO EDUCATE THE STAFF ON PROPER USE OF THE LIGHT SOURCE AND THE MODES. NO TROUBLE FOUND WITH THE SYSTEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FIELD EVALUATION. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO IMPROPER CUSTOMER SETUP. BASED ON FSE FIELD EVALUATION, THE SYSTEM ISSUE WAS DUE TO THE LIGHT SOURCE NOT BEING PROPERLY TURNED OFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CAMERA BOX WAS ON, BUT THE LIGHT SOURCE WAS NOT WHEN THE STAFF NOTICED SMOKING COMING FROM THE CAMERA DRAPING. THE CALLER STATED THE LIGHT GUIDE WAS GLOWING INDICATING THE LIGHT SOURCE WAS ON. TECHNICAL SUPPORT ENGINEER (TSE) SHARED THAT IF THE LIGHT GUIDE WAS GLOWING, IT WAS LIKELY THAT THE LIGHT SOURCE WAS ON. CUSTOMER STATED THE STAFF HAD TO POUR WATER ON THE DRAPING FOR SAFETY REASONS AND REPORTED NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PROCEDURE WAS DELAYED ROUGHLY 20 MINUTES BECAUSE THEY HAD TO THROW WATER ON THE DRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687334 NIR HANDHELD CAMERA CAMERA SYSTEM, NIR FI LIGHT SOURCE GCJ SCHOELLY FIBEROPTIC GMBH 470655-01 470655

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES