BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24640628 · Received March 19, 2026

    Report

    Report Number
    2955842-2026-16578
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    April 30, 2025
    Report Date
    March 19, 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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO INVESTIGATE THE EVENT. FSE DEMONSTRATED THE APPROPRIATE WAY TO TURN THE CAMERA HEAD ON AND OFF FROM THE LIGHT BOX. FSE PROVIDED GUIDANCE TO THE CUSTOMER REGARDING CAMERA FUNCTIONALITY, AND DETERMINED THE CAMERA AND THE SYSTEM WERE FUNCTIONING NORMALLY. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THE COMPLAINT RELATED TO THE NIR HANDHELD LIGHT SOURCE BURNING THROUGH THE PATIENT DRAPE IS ATTRIBUTED TO USER ERROR. THE FSE DETERMINED THAT THE LIGHT WAS INADVERTENTLY TURNED ON DURING THE PROCEDURE WHEN THE LIGHT CORD WAS NOT ATTACHED TO THE SCOPE, LEADING TO THE BURNING OF THE DRAPE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE, INDICATING NO FAULT WITH THE CAMERA OR LIGHT SOURCE ITSELF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE NEAR INFRARED (NIR) HANDHELD CAMERA LIGHT GUIDE BURNED A HOLE THROUGH THE STERILE DRAPE. THE CUSTOMER TURNED THE LIGHT OFF FROM THE HANDHELD CAMERA BEFORE SETTING IT DOWN. THE CUSTOMER SAW A RED LIGHT AND THE HANDHELD CAMERA LIGHT GUIDE FELT HOT, AND THAT WAS WHEN THEY NOTICED THE DRAPE WAS BURNING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INJURY. 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. IT WAS NOTED THAT THERE HAVE BEEN PRIOR DRAPE BURNS IN OTHER PROCEDURES, BUT THERE HAS NOT BEEN A PATIENT INJURY DUE TO PRIOR DRAPE BURNS. SPECIFIC DATES AND PROCEDURES WERE NOT AVAILABLE OR KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705188 NIR HANDHELD CAMERA CAMERA SYSTEM, NIR FI LIGHT SOURCE GCJ SCHOELLY FIBEROPTIC GMBH 470655-01 N/A

    Patients

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