BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT GUIDE

    MDR report key: 24689925 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17834
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Report Date
    March 25, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) SPOKE WITH THE SURGICAL ASSIST WHO HAD THE ISSUE WITH THE CAMERA AND LIGHT CABLE. FSE SHOWED THE ASSIST HOW THE LIGHT CABLE WORKS AND HOW TO TURN IT ON AND OFF FROM THE CAMERA HEAD AND FROM THE LIGHT BOX. FSE SHOWED THE ASSIST HOW THE LIGHT SOURCE CAN TOGGLE BETWEEN THE NIR AND THE WHITE LIGHT. THE ASSIST STATED THAT SOMEHOW THE LIGHT WAS TURNED BACK ON DURING THE CASE AND THAT IT BURNED THE DRAPE. FSE SPOKE WITH THE ROBOTICS MANAGER ABOUT THE FUNCTIONALITY OF THE CAMERA AND LIGHT SOURCE WITH THE ASSIST, AND THAT THERE WAS NOTHING WRONG WITH THE CAMERA OR LIGHT SOURCE, THAT SOMEONE MUST HAVE INADVERTENTLY TURNED THE LIGHT ON DURING THE CASE WHEN THE LIGHT CORD WAS NOT ATTACHED TO THE SCOPE. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE LIGHT CAMERA SOURCE AND LIGHT CORD BURNED A HOLE THROUGH THE STERILE DRAPE. THE LAPAROSCOPIC SYSTEM WAS USED FOR PORT PLACEMENT. BEFORE TRANSITIONING TO THE ROBOTIC CAMERA, THE LAPAROSCOPE WAS REMOVED FROM THE CAMERA AND HANDED OFF TO THE FIELD. THE CAMERA HEAD AND LIGHT CORD WERE THEN TUCKED INTO THE POUCH OF THE DRAPE. AT SOME POINT, THE BUTTON TO ACTIVATE THE LIGHT WAS INADVERTENTLY PRESSED, RESULTING IN A HOLE BEING BURNED THROUGH THE DRAPE. THERE WAS NO PATIENT INJURY DUE TO THE EVENT. THIS COMPLAINT CAPTURES MULTIPLE EVENTS WHERE THE STERILE DRAPE WAS BURNED. THE SITE WAS UNABLE TO PROVIDE SPECIFIC DATES, PROCEDURES, OR HOW MANY TIMES IT HAS OCCURRED. THE SITE WAS UNABLE TO IDENTIFY IF THE DRAPE BURNS OCCURRED DURING DV5 OR XI DA VINCI PROCEDURES. THERE WERE NO REPORTED PATIENT INJURY DUE TO THE STERILE DRAPE BURN AT THIS SITE. INTUITIVE FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO PATIENT INJURY DUE TO THE EVENT. THE BEDSIDE ASSISTANT PASSED THE LAPAROSCOPE CAMERA OFF THE SURGICAL FIELD BUT KEPT THE LIGHT SOURCE CORD AND TUCKED IT INTO THE STERILE DRAPE POCKET. IT WAS BELIEVED THAT THE LIGHT SOURCE WAS TURNED OFF. DURING THE PROCEDURE, THE BEDSIDE ASSISTANT NOTICED A RED LIGHT FROM THE LIGHT SOURCE, THE CORD WAS WARM, AND IT WAS THEN IDENTIFIED THAT THE DRAPE HAD BURNED. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749388 LIGHT GUIDE CAMERA SYSTEM, NIR FI LIGHT SOURCE GCJ SCHOELLY FIBEROPTIC GMBH 470656-01 N/A

    Patients

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