BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTEN

    MDR report key: 16512454 · Received March 9, 2023

    Report

    Report Number
    9710055-2023-00201
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    January 24, 2023
    Report Date
    March 9, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF H4 MANUFACTURE DATE DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H4 MANUFACTURE DATE: 2007-02-01. CORRECTED H4 MANUFACTURE DATE: 2007-02-16. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - XTEN. INITIALLY THE ISSUE, AS RECEIVED, WAS NOT CONSIDERED AS SAFETY RELATED. HOWEVER, DURING THE INSPECTION PERFORMED BY A GETINGE TECHNICIAN ON 24TH FEBRUARY 2023, IT WAS REVEALED THAT THE RUST BUILD-UP ON THE DEVICE AND THE SUSPENSION ARM CONNECTION, HAD SEIZED, CREATING THE RISK OF PARTICLES FALLING IN THE PROCEDURE ZONE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. BASED ON THE INFORMATION COLLECTED TO DATE IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET THE MANUFACTURER¿S SPECIFICATION, SINCE RUST AND OXIDATION COULD BE CONSIDERED AS A MALFUNCTION, AND IN THIS WAY DEVICE CONTRIBUTED TO EVENT. THERE IS NO INFORMATION THAT THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. A ROOT CAUSE WAS ANALYZED BY SUBJECT MATTER EXPERTS AT MANUFACTURING SITE. AS STATED, THE MOST PROBABLE ROOT CAUSE OF THIS INCIDENT ARE: HIGHER HUMIDITY IN THE OPERATING ROOM. WATER INGRESS. FUMIGATION TREATMENT (NOT APPROVED BY MAQUET SAS). THE USER MANUAL MENTIONS ALL THE RECOMMENDATIONS ABOUT THE ENVIRONMENTAL CONDITIONS FOR USE (IFU FOR XTEN 0130103 3A, PAGE 24). THE USER MANUAL EXPLAINS HOW TO CHECK THE DEVICES DURING DAILY INSPECTION (IFU FOR XTEN 0130103 3A, PAGE 26). MAQUET SAS RECOMMENDS TO INFORM THE CUSTOMERS ABOUT THE HAZARDS IN CASES OF NON-COMPLIANCE OF THESE INSTRUCTIONS. ADDITIONALLY, TAKING INTO ACCOUNT INFORMATION PROVIDED BY GETINGE TECHNICIAN, THE LAST MAINTENANCE WAS PERFORMED IN 2018. BECAUSE OF THIS LACK OF MAINTENANCE COMBINED WITH OXIDATION, THE BRAKES HAD SEIZED. WE BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION HAD BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER WAS A BIOMEDICAL DEPARTMENT EMPLOYEE. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ON 24TH JANUARY 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - XTEN. INITIALLY CLAIMED ISSUE WAS NOT CONSIDERED AS SAFETY RELATED, HOWEVER, DURING THE INSPECTION PERFORMED BY THE GETINGE TECHNICIAN ON 24TH FEBRUARY 2023 IT WAS REVEALED THAT THE RUST BUILD UP ON THE DEVICE AND THE SUSPENSION ARM CONNECTION WAS SEIZED CREATING THE RISK OF FALLING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626019 XTEN LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown