BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 2450

    MDR report key: 20224203 · Received September 16, 2024

    Report

    Report Number
    3007305485-2024-00136
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    August 8, 2024
    Report Date
    November 7, 2024
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT COMPANY
    Product Code
    GEI
    PMA / PMN Number
    K052009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE CUSTOMER ALSO REPORTED, ¿NO FAULT FOUND ON EQUIPMENT ¿ THE UNIT FUNCTIONED CORRECTLY.¿ THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF (B)(4) REPORTS, REGARDING (B)(4) DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: ELECTROSURGERY SHOULD NEVER BE PERFORMED IN THE PRESENCE OF FLAMMABLE ANESTHETICS, FLAMMABLE PREP SOLUTIONS OR DRAPES, OXIDIZING GASES SUCH AS NITROUS OXIDE (N2O) OR IN OXYGEN-ENRICHED ENVIRONMENTS. THE RISK OF IGNITING FLAMMABLE GASES OR OTHER MATERIALS IS INHERENT IN ELECTROSURGERY AND CANNOT BE ELIMINATED BY DEVICE DESIGN. PRECAUTIONS MUST BE TAKEN TO RESTRICT FLAMMABLE MATERIALS AND SUBSTANCES FROM THE ELECTROSURGICAL SITE. THEY MAY BE PRESENT IN THE FORM OF AN ANESTHETIC, LIFE SUPPORT, SKIN PREPARATION AGENT, PRODUCED BY NATURAL PROCESSES WITHIN BODY CAVITIES OR ORIGINATE IN SURGICAL DRAPES, TRACHEAL TUBES OR OTHER MATERIALS. DUE TO THE DANGER OF IGNITION OF ENDOGENOUS GASES, THE BOWEL SHOULD BE PURGED AND FILLED WITH NONFLAMMABLE GAS PRIOR TO ABDOMINAL SURGERY. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    UPDATE: "NO FAULT FOUND ON EQUIPMENT ¿ THE UNIT FUNCTIONED CORRECTLY." "THE SURGERY WAS COMPLETED AS PLANNED, BUT WITH A DELAY DUE TO THE FIRE AND ALSO SIGNIFICANT EXTRA TREATMENT REQUIRED FOR THE PATIENT DUE TO BURNS IN THE FACE/NECK. COMPLETION OF SURGERY WAS DELAYED DUE TO THE FIRE... OVERALL DELAY IN REGION OF 45-90MINS RANGE.". THE PATIENT AND THE SURGEON WERE INJURED "PATIENT WAS TRANFERRED TO ITU FOR ASSESSMENT AND CARE OF POTENTIAL AIRWAY BURN AND ONGOING ANALGESIA AND CARE OF SKIN BURNS. - REGIONAL BURNS UNIT WAS INFORMED AND ADVISED ON MANAGEMENT OF PATIENT. SURGEON REQUIRED DRESSINGS TO HAND BURN, NO OTHER TREATMENT NEEDED.". THE PATIENT HAS SINCE BEEN DISCHARGED... THE PATIENT WAS PLANNED FOR A SINGLE NIGHT STAY; BUT HAD MULTIDAY STAY. THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MHRA REPORT (B)(4). THE 60-2450-230, SYSTEM 2450 230 - 240 VAC 50/60 HZ ELECTROSURGICAL UNIT WAS REPORTED AS HAVING BEEN USED AND¿ DURING SURGERY FOR EXCISION OF FACIAL LESION WITH NASAL OXYGEN [SEPARATE REPORT RAISED FOR NASAL OXYGEN DEVICE], PATIENT'S BEARD AND SURGICAL DRAPES CAUGHT FIRE DURING USE OF DIATHERMY DEVICE. THE PRECISE REASON FOR IGNITION DURING THE OPERATION DURING A SEEMINGLY STANDARD FACIAL SURGICAL PROCEDURE UNDER LOCAL ANAESTHETIC AND SEDATION WITH AIRWAY OXYGEN IS CURRENTLY UNKNOWN. UNTIL ANY FURTHER INFORMATION COMES TO LIGHT OR THERE IS CLARIFICATION¿. CODES E170405 AND F06 WERE REPORTED, INDICATING THE PATIENT SUSTAINED A 2ND DEGREE BURN AND DISRUPTION OF SUBSEQUENT MEDICAL PROCEDURE. CAUSE OF THE BURN IS CURRENTLY UNKNOWN; HOWEVER, THERE WAS NO REPORT OF ALLEGATION AGAINST THE SYSTEM 2450. A GOOD FAITH EFFORT HAS BEEN COMPLETED; HOWEVER, TO DATE NO INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO DEVICE WITH NO REPORT OF MALFUNCTION BEING USED DURING A PROCEDURE WHERE THE PATIENT EXPERIENCED A 2ND DEGREE BURN.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MHRA REPORT (B)(4). THE 60-2450-230, SYSTEM 2450 230 - 240 VAC 50/60 HZ ELECTROSURGICAL UNIT WAS REPORTED AS HAVING BEEN USED AND¿ DURING SURGERY FOR EXCISION OF FACIAL LESION WITH NASAL OXYGEN [SEPARATE REPORT RAISED FOR NASAL OXYGEN DEVICE], PATIENT'S BEARD AND SURGICAL DRAPES CAUGHT FIRE DURING USE OF DIATHERMY DEVICE. THE PRECISE REASON FOR IGNITION DURING THE OPERATION DURING A SEEMINGLY STANDARD FACIAL SURGICAL PROCEDURE UNDER LOCAL ANAESTHETIC AND SEDATION WITH AIRWAY OXYGEN IS CURRENTLY UNKNOWN. UNTIL ANY FURTHER INFORMATION COMES TO LIGHT OR THERE IS CLARIFICATION¿. CODES E170405 AND F06 WERE REPORTED; INDICATING THE PATIENT SUSTAINED A 2ND DEGREE BURN AND DISRUPTION OF SUBSEQUENT MEDICAL PROCEDURE. CAUSE OF THE BURN IS CURRENTLY UNKNOWN; HOWEVER, THERE WAS NO REPORT OF ALLEGATION AGAINST THE SYSTEM 2450. A GOOD FAITH EFFORT HAS BEEN COMPLETED; HOWEVER, TO DATE NO INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO DEVICE WITH NO REPORT OF MALFUNCTION BEING USED DURING A PROCEDURE WHERE THE PATIENT EXPERIENCED A 2ND DEGREE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107360 SYSTEM 2450 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| O| R NASAL OXYGEN DEVICE| NASAL OXYGEN DEVICE