BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQT

    MDR report key: 24053003 · Received January 13, 2026

    Report

    Report Number
    9710055-2026-0000010
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    December 22, 2025
    Report Date
    January 13, 2026
    Manufacturer
    MAQUET SAS
    Product Code
    FXR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE INVOLVING THE EQT SPRING ARM, WHICH IS PART OF A SURGICAL LIGHT CONFIGURATION. IT WAS REPORTED THAT THE DUST COVER OF THE SPRING ARM HAD BENT EDGES, WHICH LED TO INJURIES WHEN MEDICAL STAFF REACHED FOR THE ARM. THE INJURY REQUIRED MEDICAL INTERVENTION, AS THE STAFF MEMBER SUSTAINED FINGER CUTS THAT REQUIRED STITCHES. AS A RESULT, WE DECIDED TO REPORT THIS ISSUE, AS IT LED TO INJURY AND THE NEED FOR A MEDICAL PROCEDURE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. PROVIDED INFORMATION INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. ROOT CAUSE ANALYSIS WAS PERFORMED BY A SUBJECT MATTER EXPERT AT THE MANUFACTURER¿S, THE MOST LIKELY CAUSE IS DAMAGE TO THE PLASTIC GUIDES IN THE SPRING ARM DUE TO REPEATED REPLACEMENTS OF THE METAL DUST COVER AND ITS IMPROPER FITTING. IN CASE OF DAMAGED PLASTIC GUIDES LEADING TO IMPROPER DUST COVER FITTING, IT IS RECOMMENDED TO REPLACE THE COMPLETE SET OF SPRING ARM COVERS (NOT JUST THE METAL DUST COVER) TO ENSURE PROPER ALIGNMENT AND PREVENT COVER BENDING OR WARPING. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF G3 DATE RECEIVED BY MFG DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS G3 DATE RECEIVED BY MFG : 12/22/2026. CORRECTED G3 DATE RECEIVED BY MFG: 12/22/2025.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE EQT DEVICE ((B)(6)) BELONGS TO CONFIGURATION OF PWDII50DF VP AIM CL XHS021 K3 1011 WHICH UDI IS (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER OT# (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER OT# (B)(4).

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE INVOLVING THE EQT SPRING ARM, WHICH IS PART OF A SURGICAL LIGHT CONFIGURATION. IT WAS REPORTED THAT THE DUST COVER OF THE SPRING ARM HAD BENT EDGES, WHICH LED TO INJURIES WHEN MEDICAL STAFF REACHED FOR THE ARM. THE INJURY REQUIRED MEDICAL INTERVENTION, AS THE STAFF MEMBER SUSTAINED FINGER CUTS THAT REQUIRED STITCHES. AS A RESULT, WE DECIDED TO REPORT THIS ISSUE, AS IT LED TO INJURY AND THE NEED FOR A MEDICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55897 EQT HOLDER, CAMERA, SURGICAL FXR MAQUET SAS ARD567801151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention