BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G8E

    MDR report key: 6852915 · Received September 8, 2017

    Report

    Report Number
    9710055-2017-00059
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Date of Event
    August 15, 2017
    Report Date
    April 6, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH SURGICAL LIGHT G8 EVOLUTION DEVICE. IT WAS STATED THAT DURING SURGERY TWO SPRING ARMS HIT EACH OTHER AND THE COVER OF ONE OF THEM FELL DOWN. THE COVER DID NOT FALL IN THE OPERATING FIELD AND THE SURGERY COULD BE COMPLETED, THERE WAS NO INJURY OR CONTAMINATION REPORTED. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT-HEAD DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. AT THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS BEING USED FOR THE PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THIS IS A SINGLE, ISOLATED CASE AND THAT THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE. THE MANUFACTURER HAS PERFORMED AN INVESTIGATION FOR THAT CASE. ACCORDING TO THE RESULTS OF THE INVESTIGATION THERE ARE TWO FACTORS THAT COULD CAUSE A FALL OF PLASTIC COVER. POTENTIAL ROOT CAUSES OF THE FALL MIGHT BE DUE TO AN INCORRECT ATTACHMENT OF THE DUST COVER OR A DETACHMENT MIGHT HAPPENED DUE TO REPEATED COLLISIONS. COLLISIONS COULD OCCUR DURING HANDLING OF THE DEVICE, HOWEVER THEY ARE CONSIDERED AS AN INAPPROPRIATE USE OF THE DEVICE BY USER. THE OPERATING MANUAL INCLUDES THE INSTRUCTIONS TO PRE-POSITION THE ARMS PRIOR TO USE IN ORDER TO PREVENT DAMAGES. TO PREVENT ANY OTHER SIMILAR CASE, MAQUET SAS RECOMMENDS IN G8 EVOLUTION USER MANUAL 0138101 NU EN ES ED. 1G HOW TO PROPERLY POSITION THE SURGICAL LIGHT BEFORE THE PROCEDURE. WE BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION IN THE IFU WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THIS COMPLAINT IS CONSIDERED TO BE A SINGLE, ISOLATED EVENT WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017 MAQUET (B)(4) BECAME AWARE OF INCIDENT WITH ONE OF DEVICES-- SURGICAL LIGHT G8 EVOLUTION. IT WAS STATED THAT DURING SURGERY ARMS GOT HIT EACH OTHER AND THE COVER OF ONE OF SPRING ARM FELL OFF. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED HOWEVER WE DECIDED TO REPORT THIS ISSUE IN ABUNDANCE OF CAUTION. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633461 G8E LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1