BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SW OPERATING LAMPS

    MDR report key: 9390366 · Received November 28, 2019

    Report

    Report Number
    9710055-2019-00340
    Event Type
    Malfunction
    Date Received
    November 28, 2019
    Date of Event
    October 15, 2019
    Report Date
    June 3, 2020
    Manufacturer
    MAQUET SAS
    Product Code
    FXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. THERE IS CORRECTION OF AWARENESS DATE INCLUDED IN DESCRIBE EVENT OR PROBLEM SECTION. THIS IS BASED ON INFORMATION PROVIDED IN THE COMPLAINT RECORD. #B5: PREVIOUS DESCRIBE EVENT OR PROBLEM: ON(B)(6)2019 GETINGE WAS INFORMED ABOUT COMPLAINT THAT DURING THE OPERATION, BY USING THE CAMERA A SCREW FELL DOWN INTO THE OPERATION FIELD. THE SCREW DIDN'T FALL ON THE PATIENT, BUT IN CASE OF REOCCURRENCE WE FIND THIS SITUATION AS POTENTIAL RISK OF CONTAMINATION, SO IT WAS DECIDED TO REPORT THIS CLAIM. CORRECTED DESCRIBE EVENT OR PROBLEM: ON (B)(6)2019 GETINGE WAS INFORMED ABOUT COMPLAINT THAT DURING THE OPERATION, BY USING THE CAMERA A SCREW FELL DOWN INTO THE OPERATION FIELD. THE SCREW DIDN'T FALL ON THE PATIENT, BUT IN CASE OF REOCCURRENCE WE FIND THIS SITUATION AS POTENTIAL RISK OF CONTAMINATION, SO IT WAS DECIDED TO REPORT THIS CLAIM.

    Additional Manufacturer Narrative · 0

    GETINGE WAS INFORMED ABOUT COMPLAINT THAT DURING THE OPERATION, BY USING THE CAMERA A SCREW FELL DOWN INTO THE OPERATION FIELD. THE SCREW DIDN'T FALL ON THE PATIENT, BUT IN CASE OF REOCCURRENCE WE FIND THIS SITUATION AS POTENTIAL RISK OF CONTAMINATION, SO IT WAS DECIDED TO REPORT THE RECEIVED INFORMATION. IT WAS ESTABLISHED THAT WHEN THE ISSUE OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE COMPLAINT AS THE SCREWS ARE NOT TO FALL. IN THE TIME WHEN THE ISSUE OCCURRED THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THERE IS NO APPARENT TREND WITH THE ISSUE AT HAND, IN FACT AT THIS TIME THE ISSUE APPEARS TO BE AN ISOLATED EVENT DESPITE MANY DEVICES IN THE MARKET AND IN CONSTANT USE - AND THAT THE REPORTED MALFUNCTION HAS NEVER LEAD TO SERIOUS INJURY OR WORSE. WE CONCLUDE THAT THE ISSUE IS MOST LIKELY CAUSED BY WRONG MAINTENANCE OF THE DEVICE. THIS DEFECT IS VISUALLY DETECTABLE DURING THE INSPECTION PERFORMED BY THE USERS. WE BELIEVE THAT OVERALL, THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET.

    Description of Event or Problem · 0

    ON (B)(6)2019 GETINGE WAS INFORMED ABOUT COMPLAINT THAT DURING THE OPERATION, BY USING THE CAMERA A SCREW FELL DOWN INTO THE OPERATION FIELD. THE SCREW DIDN'T FALL ON THE PATIENT, BUT IN CASE OF REOCCURRENCE WE FIND THIS SITUATION AS POTENTIAL RISK OF CONTAMINATION, SO IT WAS DECIDED TO REPORT THIS CLAIM.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2019 GETINGE WAS INFORMED ABOUT COMPLAINT THAT DURING THE OPERATION, BY USING THE CAMERA A SCREW FELL DOWN INTO THE OPERATION FIELD. THE SCREW DIDN'T FALL ON THE PATIENT, BUT IN CASE OF REOCCURRENCE WE FIND THIS SITUATION AS POTENTIAL RISK OF CONTAMINATION, SO IT WAS DECIDED TO REPORT THIS CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183787 SW OPERATING LAMPS HOLDER, CAMERA, SURGICAL FXR MAQUET SAS ARD567508999 - ACCESSORIES

    Patients

    Seq Age Sex Outcome Treatment
    1