BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPMI LUMERA I

    MDR report key: 4930942 · Received July 20, 2015

    Report

    Report Number
    9615010-2015-00008
    Event Type
    Injury
    Date Received
    July 20, 2015
    Date of Event
    June 23, 2015
    Report Date
    November 28, 2015
    Manufacturer
    CARL ZEISS MEDITEC AG
    Product Code
    HRM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A ZEISS FIELD SERVICE ENGINEER (FSE) INSPECTED THE OPMI LUMERA I MICROSCOPE AND CONFIRMED THAT THE INSTRUMENT IS WORKING WITHIN MFG'S SPEC. THE FSE FOUND THAT THE USER ADJUSTABLE SAFETY HEIGHT LIMIT SCREW WHICH PREVENTS THE MICROSCOPE FROM MOVING BELOW A SET HEIGHT AND CONTACTING THE PT, WAS SET INCORRECTLY. THE FSE RETRAINED A STAFF PERSON ON HOW TO BALANCE THE MICROSCOPE AND HOW TO SET THE SAFETY HEIGHT LIMIT SCREW. THE FSE ALSO INFORMED THE TECH WORKING FOR THE RENTAL COMPANY THAT PROVIDED THE MICROSCOPE TO THE HOSPITAL. A CORRECTLY BALANCED SCOPE CANNOT DRIFT DOWN ON ITS OWN.

    Additional Manufacturer Narrative · 1

    CORRECTED AND ADDED INFORMATION: FIELD ADDED "FEMALE" SELECTION; FIELD CHANGED FROM (B)(6) 2015 TO (B)(6) 2015 (TYPO); FIELD CHANGED FROM (B)(6) 2015 TO (B)(6) 2015 (TYPO); FIELD CHANGED "INITIAL", "30-DAY" TO "FOLLOW-UP # 1"; FIELD SPECIFIED FOLLOW UP TYPE OF THIS REPORT WITH "CORRECTION" AND "ADDITIONAL INFORMATION"; FIELD UPDATED MANUFACTURER NARRATIVE RELATED TO FIELD SERVICE ENGINEER FINDINGS (CORRECTION). MANUFACTURER NARRATIVE: THE FSE DETERMINED THAT THE USER ADJUSTABLE SAFETY HEIGHT LOCKING LEVER WHICH PREVENTS THE MICROSCOPE FROM MOVING BELOW A SET HEIGHT AND CONTACTING THE PATIENT WAS NOT SET BY THE TECHNICIAN FROM THE 3RD PARTY RENTAL AGENCY CONTRACTED BY THE USER FACILITY. THE FSE RETRAINED THE TECHNICIAN FROM THE 3RD PARTY RENTAL AGENCY CONTRACTED BY THE USER FACILITY ON HOW TO BALANCE THE MICROSCOPE AND HOW TO SET THE SAFETY HEIGHT LOCKING LEVER.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THE FOLLOWING: AT THE CONCLUSION OF A CATARACT SURGERY, THE DOCTOR RAISED THE ARM OF THE OPMI LUMERA I MICROSCOPE TO THE STANDBY POSITION. THE MICROSCOPE HEAD THEN DROPPED DOWN SUDDENLY FROM THAT POSITION AND MADE CONTACT WITH THE PT'S NOSE. THE IMPACT RESULTED IN A SMALL TRIANGULAR SHAPED -5-6 MM LACERATION ON THE BRIDGE OF THE PT'S NOSE WITH BLEEDING. THE LACERATION WAS TREATED AND DRESSED WITH STERI STRIPS. THE OPMI LUMERA I MICROSCOPE WAS USED FOR SURGERIES BEFORE AND AFTER THIS CASE, WITHOUT INCIDENT.

    Description of Event or Problem · 1

    NA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469709 OPMI LUMERA I MICROSCOPE, OPHTHALMIC, OPERATING HRM CARL ZEISS MEDITEC AG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other