BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCINTILLANT SURGICAL LIGHT

    MDR report key: 13177596 · Received January 6, 2022

    Report

    Report Number
    3005977121-2022-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    November 2, 2021
    Report Date
    February 18, 2022
    Manufacturer
    ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED
    Product Code
    FTD
    UDI-DI
    10865082000150
    PMA / PMN Number
    K133425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE LIGHT WAS REQUESTED TO BE RETURNED. ADDITIONAL INFORMATION WAS ALSO REQUESTED. INVESTIGATION IS PENDING UNTIL MORE INFORMATION CAN BE RECEIVED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE PRODUCT. THE MANUFACTURER REACHED OUT TO A QUALIFIED ELECTRICAL TESTING LABORATORY. THERE WAS NOT ENOUGH INFORMATION FROM THE EVENT TO ADEQUATELY TEST A SCINTILLANT SURGICAL LIGHT OF THE SAME MODEL TO THE SAME CONDITIONS EXPERIENCED BY THE DEVICE IN THE EVENT. THE SCINTILLANT SURGICAL LIGHT WAS PREVIOUSLY TESTED AND MET ACCEPTANCE CRITERIA FOR ALL APPLICABLE MEDICAL ELECTRICAL REQUIREMENTS IN THE IEC 60601 STANDARD. THE TESTING CONTINUES TO BE REVIEWED AND UPDATED WHEN NEEDED WHEN REVISIONS OR AMENDMENTS ARE RELEASED FOR THE APPLICABLE IEC 60601-1 AND IEC 60601-1-2 STANDARDS.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A LIGHT SOURCE USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS EXTENSIVE SPINAL CANAL STENOSIS, DEGENERATIVE SCOLIOSIS. REVISION SURGERY PERFORMED DUE TO RELAPSE OF SYMPTOM AFTER INITIAL DECOMPRESSION. IT WAS REPORTED THAT INTRA-OPERATIVELY, SPARKS CAME OUT TWICE FROM THE TIP OF THE LIGHT SOURCE IN THE SURGICAL FIELD. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE REPORTED THAT THE SPARKS OCCURRED TWICE ON ONE SIDE. TIMING OF THE FIRST SPARK AND THE OPERATION IMMEDIATELY BEFORE: SURGEON WAS OPERATING WITH AN ELECTRIC CAUTERY. TIMING OF THE SECOND SPARK AND THE OPERATION IMMEDIATELY BEFORE: SURGEON WAS OPERATING WITH AN ELECTRIC CAUTERY. THE PHYSICIAN HAD CONFIRMED THAT THERE WAS NO INJURY SUCH AS BURNS OR DISCOLORATION IN THE PATIENT'S SURGICAL FIELD DUE TO SPARKS. THERE WAS ALSO NO HEALTH DAMAGE TO THE SURGEON. AS A SUPPLEMENT, AFTER THE SECOND SPARK, SURGEON REMOVED IT IMMEDIATELY CONSIDERING THAT THE PRODUCT WAS BATTERY POWERED AND REPLACED IT WITH A NEW ONE. THE PRODUCT WAS KEPT IN A CLEAN BAG AS IT WAS FROM THE CLEAN TABLE, AND WHEN TOUCHED THE TIP, ONLY THE TIP ON THE SIDE WHERE THE SPARK CAME OUT HAD HEAT. SURGEON STUCK A CURING TAPE TO THE REPORTED PRODUCT SO THAT THEY CAN KNOW THAT SIDE. THE PATIENT HAS A HISTORY OF SURGERY, BUT THERE IS NO HISTORY OF DISORDER TO BE NOTED SPECIALLY. THERE WAS ALSO NO INFECTION. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE REPORTED THAT THE PRODUCT DID NOT TOUCH THE PATIENT DIRECTLY, BUT SINCE IT IS A PRODUCT USES INSIDE THE BODY, THEY PUT THE TIP INSIDE THE BODY. PROCEDURE PERFORMED WAS ANTERIOR LUMBAR FUSION.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A LIGHT SOURCE USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS EXTENSIVE SPINAL CANAL STENOSIS, DEGENERATIVE SCOLIOSIS. REVISION SURGERY PERFORMED DUE TO RELAPSE OF SYMPTOM AFTER INITIAL DECOMPRESSION. IT WAS REPORTED THAT INTRA-OPERATIVELY, SPARKS CAME OUT TWICE FROM THE TIP OF THE LIGHT SOURCE IN THE SURGICAL FIELD. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE REPORTED THAT THE SPARKS OCCURRED TWICE ON ONE SIDE. TIMING OF THE FIRST SPARK AND THE OPERATION IMMEDIATELY BEFORE: SURGEON WAS OPERATING WITH AN ELECTRIC CAUTERY. TIMING OF THE SECOND SPARK AND THE OPERATION IMMEDIATELY BEFORE: SURGEON WAS OPERATING WITH AN ELECTRIC CAUTERY. THE PHYSICIAN HAD CONFIRMED THAT THERE WAS NO INJURY SUCH AS BURNS OR DISCOLORATION IN THE PATIENT'S SURGICAL FIELD DUE TO SPARKS. THERE WAS ALSO NO HEALTH DAMAGE TO THE SURGEON. AS A SUPPLEMENT, AFTER THE SECOND SPARK, SURGEON REMOVED IT IMMEDIATELY CONSIDERING THAT THE PRODUCT WAS BATTERY-POWERED AND REPLACED IT WITH A NEW ONE. THE PRODUCT WAS KEPT IN A CLEAN BAG AS IT WAS FROM THE CLEAN TABLE, AND WHEN TOUCHED THE TIP, ONLY THE TIP ON THE SIDE WHERE THE SPARK CAME OUT HAD HEAT. SURGEON STUCK A CURING TAPE TO THE REPORTED PRODUCT SO THAT THEY CAN KNOW THAT SIDE. THE PATIENT HAS A HISTORY OF SURGERY, BUT THERE IS NO HISTORY OF DISORDER TO BE NOTED SPECIALLY. THERE WAS ALSO NO INFECTION. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE REPORTED THAT THE PRODUCT DID NOT TOUCH THE PATIENT DIRECTLY, BUT SINCE IT IS A PRODUCT USES INSIDE THE BODY, THEY PUT THE TIP INSIDE THE BODY. PROCEDURE PERFORMED WAS ANTERIOR LUMBAR FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616805 SCINTILLANT SURGICAL LIGHT SURGICAL LIGHT FTD ENGINEERED MEDICAL SOLUTIONS CO. LLC DBA BIHLERMED 2762-01-0004 11251 10865082000150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown