BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIR HANDHELD CAMERA

    MDR report key: 24646022 · Received March 19, 2026

    Report

    Report Number
    2955842-2026-16571
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    July 18, 2025
    Report Date
    April 7, 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
    ID, US
    Reporter Occupation
    003

    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. SITE MENTIONED THAT PROCEDURE WAS ABLE TO BE COMPLETED. NO INJURY TO THE PATIENT OR STAFF. THERE WAS A BLANKET UNDER THE DRAPE SO THE LIGHT CORD DID NOT DIRECTLY TOUCH THE PATIENT. 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. WHILE THE DEFINITIVE ROOT CAUSE IS NOT ESTABLISHED, POSSIBLE CAUSE IS ATTRIBUTED TO USAGE-RELATED CONDITIONS; KEEPING THE LIGHT SOURCE/CORD/LAPAROSCOPE IN CLOSE PROXIMITY TO DRAPES. A RISK ITEM CANNOT BE TRACED TO THIS EVENT AS THIS INTUITIVE IS CONSIDERED TO BE A DISTRIBUTOR OF THIS MEDICAL DEVICE. SCHÖLLY FIBEROPTIC GMBH IS THE MANUFACTURER OF THIS MEDICAL DEVICE AND OWNS THE RISK MANAGEMENT FILE. THE IFU (INSTRUCTIONS FOR USE; SCHOELLY LIGHT SOURCE; PN: 557071-01) ADVISES SAFETY PRECAUTIONS TO THE USER ON PAGE 27.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. 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

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INGUINAL HERNIA PROCEDURE, AN INCIDENT OCCURRED INVOLVING THE USE OF AN NIR CAMERA. THE CAMERA LIGHT CORD WAS TURNED ON AND SET ON THE DRAPE FOR ABOUT 5 SECONDS, WHICH RESULTED IN THE DRAPE BEING BURNED. THE SURGEON NOTED THAT THE LIGHT CORD WAS EXTREMELY HOT. IT WAS UNCLEAR WHETHER THE PATIENT WAS INJURED OR WHAT INTERVENTIONS WERE TAKEN TO ADDRESS THE ISSUE. THE PROCEDURE WAS COMPLETED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER INFORMED THERE WAS NO INJURY TO THE PATIENT OR STAFF. THERE WAS A BLANKET UNDER THE DRAPE AND THE LIGHT CORD DID NOT DIRECTLY TOUCH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707091 NIR HANDHELD CAMERA CAMERA SYSTEM, NIR FI LIGHT SOURCE GCJ SCHOELLY FIBEROPTIC GMBH 470655-01 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES