BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT GUIDE

    MDR report key: 24704493 · Received March 26, 2026

    Report

    Report Number
    2955842-2026-17824
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    December 10, 2024
    Report Date
    March 26, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN AS THE CUSTOMER DID NOT CREATE AN RMA FOR THE INCIDENT. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT INGUINAL HERNIA SURGICAL PROCEDURE, THE LIGHT CABLE GOT SO HOT THAT IT BURNED A HOLE IN THE MONOPOLAR CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO INJURY OR BURN TO THE OR STAFF/PATIENT. IT WAS WRONGLY MENTIONED. THE ISSUE WAS THAT THE CABLE GETS VERY HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761609 LIGHT GUIDE CAMERA SYSTEM, NIR FI LIGHT SOURCE GCJ SCHOELLY FIBEROPTIC GMBH 470656-01 470656

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES