BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M720 OH5

    MDR report key: 19236147 · Received May 3, 2024

    Report

    Report Number
    3003974370-2024-00004
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    March 12, 2024
    Report Date
    August 20, 2024
    Manufacturer
    LEICA MICROSYSTEMS (SCHWEIZ) AG
    Product Code
    EPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS IS A FINAL REPORT. THE LOCAL FIELD SERVICE ENGINEER, WITH THE SUPPORT OF THE HOSPITAL'S BIOMEDICAL ENGINEER, CONDUCTED AN ON-SITE INSPECTION OF THE ACTUAL DEVICE. SPECIFICALLY, THE BRIGHTCARE AND AUTOIRIS SAFETY FEATURES WERE CHECKED. BOTH WERE FUNCTIONING AS INTENDED. THE FSE CONFIRMED THAT THE DEVICE PERFORMED AS PER SPECIFICATION, WITH NO INDICATION OF MALFUNCTION. IT WAS FOUND THAT THE XENON BULB HAD BEEN REPLACED. HOWEVER, INSTEAD OF REPLACING THE ENTIRE COMPONENT, THE INTERNAL XENON BULB WAS REMOVED AND THE OUTER BLUE HOUSING OF THE XENON LAMP MODULE WAS REUSED. IN ADDITION, THE WRONG AFTERMARKET BULB WITH A HIGHER UV/IR LEVEL WAS INSERTED, AS TESTS SHOWED. THE CUSTOMER NOT ONLY DID NOT USE THE APPROVED XENON LAMP, BUT HAS ALSO MADE AN UNAUTHORIZED MODIFICATION. THE USER MANUAL CLEARLY STATES THAT ONLY APPROVED AND ORIGINAL REPLACEMENT PARTS ARE TO BE USED. IN ADDITION THE SURGEONS ADMITTED THAT THEY TURN OFF THE BRIGHTCARE SAFETY FEATURE WHEN THEY NEED MORE LIGHT. AS FOR THE AUTOIRIS SAFETY FEATURE WE DO NOT KNOW WHETHER IT WAS DISABLED. BOTH FUNCTIONS ARE EXPLAINED IN DETAIL IN THE USER MANUAL. A REVIEW OF THE SERVICE HISTORY RECORDS AND THE COMPLAINT DATABASE REVEALED NO ISSUES THAT COULD EXPLAIN THE COMPLAINT. A REVIEW OF THE USER MANUAL SHOWED THAT THE RELEVANT INSTRUCTIONS ARE ADEQUATE. BASED ON THE INVESTIGATION RESULTS, WE CONCLUDE THAT IT IS UNLIKELY THAT THE DEVICE ITSELF WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED SKIN BURNS IF THE APPROVED XENON LAMP HAD BEEN USED AND THE SAFETY FEATURES HAD BEEN ACTIVATED AS PER THE USER MANUAL. THE REPORTED INCIDENT CAN BE TRACED TO USER NOT FOLLOWING THE INSTRUCTIONS FOR USE. THE FSE ENSURED THAT THE APPROVED 300W XENON LAMP WAS INSTALLED. IN ADDITION, THE USER WAS RE-TRAINED, FOCUSING ON BRIGHTCARE AND AUTOIRIS TO PREVENT FURTHER SKIN BURNS.

    Description of Event or Problem · 0

    ON 03 MAY 2024 WE REPORTED THAT LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM CANADA STATING THAT USERS HAVE SEEN A RISE IN PATIENT BURNS FROM THEIR M720 OH5. THEY SAID THAT IN THE PAST 4 WEEKS, FIVE (5) PATIENTS WERE DISCOVERED TO HAVE BURNS AFTER SURGERY WAS COMPLETED. THE DATE(S) OF EVENT(S) WERE NOT COMMUNICATED BY THE CUSTOMER. THE ISSUE WAS BROUGHT UP ON APRIL 16TH, 2024. LATER THAT SAME DAY (03 MAY 2024), WE RECEIVED CORRECTED/ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT SIX (6) PATIENTS WERE DISCOVERED TO HAVE BURNS AFTER SURGERY WAS COMPLETED. THE CUSTOMER COMMUNICATED THE FOLLOWING DATES OF EVENTS AND DESCRIPTION OF THE BURNS: (B)(6) 2024; LEFT COCHLEAR IMPLANT; SEVERE FULL THICKNESS BURN BACK OF PINNA, (B)(6) 2024; RIGHT STAPEDECTOMY; EARLOBE AND SURROUNDING SKIN BURN, (B)(6) 2024; LEFT OSSICULOPLASTY AND TYMPANOPLASTY; FULL THICKNESS BURN OF TRAGUS AND SURROUNDING SKIN, (B)(6) 2024; TYMPANOPLASTY WITH CARTILAGE GRAFT; SEVERE BURNING POST OP PAIN, (B)(6) 2024; LEFT STAPEDECTOMY; EARLOBE AND SURROUNDING SKIN, (B)(6) 2024; RIGHT TYMPANOMASTOIDECTOMY; BACK OF PINNA AND SURROUNDING SKIN BURN.

    Description of Event or Problem · 0

    LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM CANADA STATING THAT USERS HAVE SEEN A RISE IN PATIENT BURNS FROM THEIR M720 OH5. THEY SAID THAT IN THE PAST 4 WEEKS, FIVE (5) PATIENTS WERE DISCOVERED TO HAVE BURNS AFTER SURGERY WAS COMPLETED. THE DATE(S) OF EVENT(S) WERE NOT COMMUNICATED BY THE CUSTOMER. THE ISSUE WAS BROUGHT UP ON APRIL 16TH, 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420305 M720 OH5 SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS (SCHWEIZ) AG M720 OH5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other