BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTEN

    MDR report key: 11001719 · Received December 14, 2020

    Report

    Report Number
    9710055-2020-00509
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Report Date
    September 13, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ON 8TH DECEMBER, 2020 GETINGE BECAME AWARE OF AN ISSUE WITH X-TEN SURGICAL LIGHTS. AS IT WAS STATED, THE HANDLES WERE DAMAGED RESULTING IN FALLING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET THE MANUFACTURER¿S SPECIFICATION AS THE DEGRADATION OF HANDLES OCCURRED, THE DEVICE STATE ITSELF CONTRIBUTED TO THE REPORTED SITUATION. THE PROVIDED INFORMATION DID NOT INDICATE THAT THE DEVICE WAS BEING USED FOR PATIENT TREATMENT WHEN AN EVENT TOOK PLACE. DURING THE INVESTIGATION IT WAS FOUND THAT THE REPORTED SCENARIO HAS NEVER LEAD, TO DATE, TO SERIOUS INJURY OR WORSE, AS FAR AS GETINGE IS AWARE. THE DAMAGES ON THE PLASTIC HANDLE SHOWS A DETERIORATION OF THE SURFACE. THE DETERIORATION OF THE SURFACE WAS PROBABLY CAUSED BY AGGRESSIVE CLEANING PRODUCTS USED DURING THE CLEANING OR BY LIQUID RESIDUES LEFT ON THE HANDLES. TO PREVENT ANY SAFETY ISSUE THE XTEN USER MANUAL # 0130103 REV. 3A MENTIONS THE PROCEDURE TO CLEAN THE DEVICE INDICATING THE PROHIBITED PRODUCTS AND INDICATING TO RINSE THE DEVICE WITH CLEAN WATER IN ORDER TO REMOVE RESIDUES AFTER CLEANING. THE XTEN USER MANUAL # 0130103 REV. 3A MENTIONS TO CHECK THE LIGHT HEADS FOR CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGE, DURING THE DAILY CHECK; AND MENTIONS TO CHECK THE OVERALL CONDITION OF THE SIDE HANDLES, DURING ANNUAL CHECKS. NEW HANDLES AVAILABLE AS SPARE PARTS WERE INSTALLED IN ORDER TO REPLACE THE DAMAGED HANDLES AND TO AVOID ANY INCIDENT. MAQUET SAS RECOMMENDS TO INFORM THE CUSTOMERS ABOUT THE HAZARDS IN CASES OF NON-COMPLIANCE OF THESE INSTRUCTIONS. WE BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED. THE CORRECTION OF D4 CATALOG # FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 CATALOG # ARD267800999. CORRECTED D4 CATALOG # ARD567813999 & ARD567814999.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2020 GETINGE BECAME AWARE OF AN ISSUE WITH X-TEN SURGICAL LIGHT. AS IT WAS STATED, THE HANDLES WERE DAMAGED RESULTING IN FALLING PARTICLES. THERE WAS NO INJURY REPORTED, HOWEVER, 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
    1469914 XTEN LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD267800999

    Patients

    Seq Age Sex Outcome Treatment
    1