BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTEN

    MDR report key: 8892138 · Received August 14, 2019

    Report

    Report Number
    9710055-2019-00256
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Report Date
    February 27, 2020
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE IS BEING INVESTGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- X-TEN. AS IT WAS STATED, THE PAINT WAS CHIPPING FROM THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PAINT PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY BE A SOURCE OF CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. THE PROVIDED INFORMATION DID NOT INDICATE THAT THE DEVICE WAS BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. DURING THE INVESTIGATION IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LED TO SERIOUS INJURY, NOR DEATH. THE PEELED PAINT IS MOST LIKELY CAUSED BY A STAGNATION OF AGGRESSIVE DISINFECTANT AND DETERGENT PRODUCTS DUE TO AN INAPPROPRIATE CLEANING OR DISINFECTION PROTOCOL. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATIONS WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. THERE IS ALSO CORRECTION OF AWARENESS DATE INCLUDED IN DESCRIBE EVENT OR PROBLEM SECTION. THIS IS BASED ON THE RESULT OF AN INTERNAL REVIEW NOTING THE REPORT WAS INCORRECTLY SUBMITTED STATING AWARENESS DATE DIFFERENT THAN INCLUDED IN SERVICE REPORT ATTACHED TO THE COMPLAINT RECORD. EVENT: PREVIOUS DESCRIBE EVENT OR PROBLEM: ON (B)(6) 2019 GETTING BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- X-TEN. AS IT WAS STATED BY CUSTOMER, THE PAINT WAS CHIPPING FROM THE DEVICE. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PAINT PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY BE A SOURCE OF CONTAMINATION. CORRECTED DESCRIBE EVENT OR PROBLEM: ON (B)(6) 2019 GETTING BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- X-TEN. AS IT WAS STATED BY CUSTOMER, THE PAINT WAS CHIPPING FROM THE DEVICE. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PAINT PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY BE A SOURCE OF CONTAMINATION.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: 233904.

    Description of Event or Problem · 0

    ON (B)(6) 2019 GETTING BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- X-TEN. AS IT WAS STATED BY CUSTOMER, THE PAINT WAS CHIPPING FROM THE DEVICE. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PAINT PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY BE A SOURCE OF CONTAMINATION.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY THE MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE

    Additional Manufacturer Narrative · 1

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 1

    ON (B)(6) 2019 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- X-TEN. AS IT WAS STATED BY CUSTOMER, THE PAINT WAS CHIPPING FROM THE DEVICE. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS ANY PAINT PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY BE A SOURCE OF CONTAMINATION.

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688704 XTEN LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD567801999

    Patients

    Seq Age Sex Outcome Treatment
    1