BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARBON FIBRE EXTENSION PLATE

    MDR report key: 20949765 · Received December 17, 2024

    Report

    Report Number
    8010652-2024-0000103
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    September 16, 2024
    Report Date
    December 17, 2024
    Manufacturer
    MAQUET GMBH
    Product Code
    BWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE FULL UNIQUE IDENTIFIER (UDI) # AND MANUFACTURING DATE INFORMATION IS NOT AVAILABLE SINCE THE SERIAL NUMBER HAS NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 143366BC - CARBON-FIBRE EXTENSION PLATE 1 USED WITH 143301B0 - YUNO OTN, SFC, EU. AS IT WAS STATED, THE CARBON COUNTER-EXTENSION BAR CAME OUT OF ITS EXTENSION HOLE CAUSING A PATIENT TO FALL DURING ORTHOPEDIC PROCEDURE. THE BRAIN SCAN WAS PERFORMED AFTER THE INCIDENT WITH THE FOLLOWING RESULTS: HEAD TRAUMA WITHOUT LESION. NO FURTHER DETAILS HAVE BEEN RECEIVED. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE PATIENT. THE INCIDENT OCCURRED IN (B)(6) 2024. SINCE THE INCIDENT A MARK WITH RED ADHESIVE TAPE HAS BEEN MADE BY USERS TO CHECK THE CORRECT INSTALLATION OF THE BAR. USERS VISUALLY CHECK IF THE BAR IS PROPERLY INSERTED AND PROTRUDES FROM THE UNDERSIDE OF THE SEAT PLATE. THE INCIDENT WAS REPORTED TO GETINGE IN (B)(6) 2024. UNTIL THEN, THE CUSTOMER CONTINUED TO USE THE DEVICE. ACCORDING TO THE CUSTOMER¿S ALLEGATION, THE COUNTER-EXTENSION BAR CUSHION IS LOOSER THAN BEFORE AND SLIDES MORE EASILY ON THE CARBON BAR. THE AFFECTED DEVICE WAS EVALUATED BY A GETINGE TECHNICIAN. DURING THE SERVICE VISIT ON SITE, NO DEFECT WAS NOTED. THE COUNTER-EXTENSION BAR FITS FREELY INTO THE 143366BC EXTENSION AND THE TRANSLATION STOP IS MADE BY THE PATIENT'S SEAT CUSHION AND THE CUSHION OF THE COUNTER-EXTENSION BARS. TO ADDRESS THE CUSTOMER¿S CONCERNS THE TESTING OF NEW PARTS WAS PROPOSED. THE QUOTATION WAS NOT ACCEPTED BY THE CUSTOMER. THE INSTRUCTION FOR USE FOR THE AFFECTED DEVICE DESCRIBES MOUNTING OF THE COUNTER TRACTION POST. THE USER IS ADVISED TO INSERT THE COUNTER TRACTION POST FROM ABOVE COMPLETELY INTO THE MOUNTING POINT AND ENSURE THAT THE COUNTER TRACTION POST IS PROPERLY SEATED (IFU 1433.66 REV. 6 PAGE 17). BASED ON ALL AVAILABLE INFORMATION IT HAS BEEN ESTABLISHED THAT THE ROOT CAUSE OF THE INVESTIGATED ISSUE WAS MOST LIKELY RELATED TO THE USER ERROR DUE TO INCORRECT MOUNTING OF THE COUNTER TRACTION POST. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS NO MALFUNCTION WITH THE DEVICE WAS REPORTED, IT HAS BEEN ASSESSED THAT THE GETINGE DEVICE WAS UP TO THE SPECIFICATION. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION REGARDING DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE CORRECTION OF B3 DATE OF EVENT AND B5 DESCRIBE EVENT OR PROBLEM FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B3 DATE OF EVENT: 12/06/2024. CORRECTED B3 DATE OF EVENT: 09/16/2024. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 143366BC - CARBON-FIBRE EXTENSION PLATE 1 USED WITH 143301B0 - YUNO OTN, SFC, EU. AS IT WAS STATED, THE CARBON COUNTER-EXTENSION BAR CAME OUT OF ITS EXTENSION HOLE CAUSING A PATIENT TO FALL DURING ORTHOPEDIC PROCEDURE. THE BRAIN SCAN WAS PERFORMED AFTER THE INCIDENT WITH THE FOLLOWING RESULTS: HEAD TRAUMA WITHOUT LESION. NO FURTHER DETAILS HAVE BEEN RECEIVED. DURING SERVICE VISIT ON SITE, NO DEFECT WAS NOTED. THE COUNTER-EXTENSION BAR FITS FREELY INTO THE 143366BC EXTENSION AND THE TRANSLATION STOP IS MADE BY THE PATIENT'S SEAT CUSHION AND THE CUSHION OF THE COUNTER-EXTENSION BARS. ACCORDING TO CUSTOMER¿S ALLEGATION, THE COUNTER-EXTENSION BAR CUSHION IS LOOSER THAN BEFORE AND SLIDES MORE EASILY ON THE CARBON BAR. WE DECIDED TO REPORT THE ISSUE DUE TO SERIOUS INJURY OF THE PATIENT. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 143366BC - CARBON-FIBRE EXTENSION PLATE 1 USED WITH 143301B0 - YUNO OTN, SFC, EU. AS IT WAS STATED, THE CARBON COUNTER-EXTENSION BAR CAME OUT OF ITS EXTENSION HOLE CAUSING A PATIENT TO FALL DURING ORTHOPEDIC PROCEDURE. THE BRAIN SCAN WAS PERFORMED AFTER THE INCIDENT WITH THE FOLLOWING RESULTS: HEAD TRAUMA WITHOUT LESION. NO FURTHER DETAILS HAVE BEEN RECEIVED. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE PATIENT.

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 143366BC - CARBON-FIBRE EXTENSION PLATE 1 USED WITH 143301B0 - YUNO OTN, SFC, EU. AS IT WAS STATED, THE CARBON COUNTER-EXTENSION BAR CAME OUT OF ITS EXTENSION HOLE CAUSING A PATIENT TO FALL DURING ORTHOPEDIC PROCEDURE. THE BRAIN SCAN WAS PERFORMED AFTER THE INCIDENT WITH THE FOLLOWING RESULTS: HEAD TRAUMA WITHOUT LESION. NO FURTHER DETAILS HAVE BEEN RECEIVED. DURING SERVICE VISIT ON SITE, NO DEFECT WAS NOTED. THE COUNTER-EXTENSION BAR FITS FREELY INTO THE 143366BC EXTENSION AND THE TRANSLATION STOP IS MADE BY THE PATIENT'S SEAT CUSHION AND THE CUSHION OF THE COUNTER-EXTENSION BARS. ACCORDING TO CUSTOMER¿S ALLEGATION, THE COUNTER-EXTENSION BAR CUSHION IS LOOSER THAN BEFORE AND SLIDES MORE EASILY ON THE CARBON BAR. WE DECIDED TO REPORT THE ISSUE DUE TO SERIOUS INJURY OF THE PATIENT.

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 143366BC - CARBON-FIBRE EXTENSION PLATE 1 USED WITH 143301B0 - YUNO OTN, SFC, EU. AS IT WAS STATED, THE CARBON COUNTER-EXTENSION BAR CAME OUT OF ITS EXTENSION HOLE CAUSING A PATIENT TO FALL DURING ORTHOPEDIC PROCEDURE. THE BRAIN SCAN WAS PERFORMED AFTER THE INCIDENT WITH THE FOLLOWING RESULTS: HEAD TRAUMA WITHOUT LESION. NO FURTHER DETAILS HAVE BEEN RECEIVED. WE DECIDED TO REPORT THE ISSUE DUE TO THE SERIOUS INJURY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487087 CARBON FIBRE EXTENSION PLATE TABLE AND ATTACHMENTS, OPERATING-ROOM BWN MAQUET GMBH 143366BC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other 143301B0 YUNO OTN, SFC, EU.