BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_COMMUNICATION_PRODUCT

    MDR report key: 14355907 · Received May 11, 2022

    Report

    Report Number
    0008010153-2022-00008
    Event Type
    Injury
    Date Received
    May 11, 2022
    Date of Event
    March 31, 2022
    Report Date
    May 16, 2022
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT TOWARDS THE END OF A THYROID SURGERY AFTER SUTURING HAD BEEN COMPLETED, IT WAS DISCOVERED THAT THE PATIENT HAD SUSTAINED A SKIN BURN. IT WAS NOTED THAT THE TEMPERATURE EMITTED FROM THE SHADOWLESS LAMP WAS VERY HIGH, PROMPTING THE MEDICAL STAFF TO TURN THE LIGHT OFF AND REMOVE IT FROM THE SURGICAL SITE. CONTACT WAS MADE WITH THE STRKER (B)(4) RAQA TEAM AND UPDATES WERE PROVIDED. IT WAS CONFIRMED THAT THERE WERE TWO LIGHTS USED DURING THE PROCEDURE. THE EXACT POSITION OF THE LIGHTS AT THE TIME THE INCIDENT OCCURRED IS UNKNOWN. REGARDING THE SKIN BURN, IT WAS NOTED THAT THE PATIENT SUSTAINED SLIGHT BURNS AND THAT THE BURNS WERE TREATED WITH OINTMENT. AFTER TREATMENT, IT WAS REPORTED THAT THAT THE AFFECTED SKIN RETURNED TO NORMAL. THERE WAS MINIMAL SURGICAL DELAY, AS THE SUTURING HAD ALREADY BEEN COMPLETED AT THE TIME THE SKIN BURN WAS DISCOVERED. DUE TO CURRENT COVID-19 CONDITIONS, A STRYKER FIELD SERVICE TEAM MEMBER HAS BEEN UNABLE TO GO ONSITE TO INVESTIGATE, AND IT IS UNKNOWN WHEN THEY WILL BE PERMITTED TO ENTER THE FACILITY. ALTHOUGH THE EXACT ROOT CAUSE OF THIS ISSUE IS UNKNOWN, THE MOST LIKELY ROOT CAUSE WOULD IMPROPER POSITIONING OF THE SURGICAL LIGHTS DUE TO USER ERROR, AS OUTLINED IN THE CHROMOPHARE E650 SURGICAL LIGHTS OPERATIONS MANUAL, PART # (B)(4) REVISION 1. PAGE 45 OF THE MANUAL DISCUSSES THE RISK OF TISSUE NECROSIS FROM HEATING OF THE SURGICAL FIELD, AND STATES THAT IF THE FILTERING SYSTEM IS DEFECTIVE, MULTIPLE LIGHT FIELDS OVERLAP, OR IF THE LIGHT IS TOO CLOSE TO THE SURGICAL FIELD, THE SURGICAL FIELD CAN OVERHEAT. THIS CAN CAUSE THE TISSUE TO HEAT UP AND DRY OUT, AND EVEN RESULT IN NECROSIS FOLLOWING EXCESSIVE EXPOSURE. THIS ISSUE HAS NOT EXCEEDED ANY THRESHOLDS AND WILL CONTINUE TO BE MONITORED PER (B)(4). IF ANY FURTHER INFORMATION IS OBTAINED, A SUPPLEMENTAL WILL BE FILED.

    Additional Manufacturer Narrative · 0

    [SUPPLEMENTAL 001] FIELD H6, RESULTS CODE GRID, WAS UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THYROID SURGERY IN NO. 29 OPERATING ROOM THE PATIENT'S SKIN UNDER THE SHADOWLESS LAMP WAS BURNING. IT WAS FURTHER REPORTED THE PATIENT WAS TREATED WITH OINTMENT AND THE BURNED SKIN PART HAS TURNED TO NORMAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THYROID SURGERY IN NO. 29 OPERATING ROOM THE PATIENT'S SKIN UNDER THE SHADOWLESS LAMP WAS BURNING. IT WAS FURTHER REPORTED THE PATIENT WAS TREATED WITH OINTMENT AND THE BURNED SKIN PART HAS TURNED TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694404 UNKNOWN_COMMUNICATION_PRODUCT LIGHT, SURGICAL, CEILING MOUNTED FSY BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other