BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA SYSTEM, NIR FI LIGHT SOURCE

    MDR report key: 24808796 · Received April 7, 2026

    Report

    Report Number
    2955842-2026-19885
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 7, 2026
    Manufacturer
    SCHOELLY FIBEROPTIC GMBH
    Product Code
    GCJ
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER TURNED IT ON FROM THE BOX AND THAT THEY DID NOT HAVE A SCOPE ATTACHED TO THE LIGHT SOURCE. THE CLINICAL SALES REP (CSR) DID A TEST DRIVE WITH THE LIGHT SOURCE AND SCOPE AND CONFIRMED IT IS WORKING AS IT SHOULD BE. NO SITE VISIT WAS CONDUCTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BIOMEDICAL ENGINEER (BIOMED) CALLED FROM OUTSIDE OF THE OPERATING ROOM TO REPORT THAT THE LIGHT SOURCE BURNED THE DRAPE. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CALLER IF SHE WAS REFERRING TO THE LIGHT GUIDE CABLE FOR THE HANDHELD CAMERA. THE CALLER WAS UNSURE AND MENTIONED THAT THE STAFF ONLY REFERRED TO IT AS THE LIGHT SOURCE. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO PATIENTS OR STAFF WERE HARMED DUE TO THE BURNING DRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863347 CAMERA SYSTEM, NIR FI LIGHT SOURCE LIGHT GUIDE GCJ SCHOELLY FIBEROPTIC GMBH 470656-01 N/A

    Patients

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