BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 296830 · Received September 12, 2000

    Report

    Report Number
    8010047-2000-00054
    Event Type
    Malfunction
    Date Received
    September 12, 2000
    Report Date
    August 17, 2000
    Manufacturer
    THE OLYMPUS OPTICAL CO. LTD.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN OLYMPUS SALES REP REPORTED THAT THE SUPPORTING INTERIOR STEEL SUPPORT BEAM LINKING THE COUNTERBALANCE WEIGHT TO THE HEAD OF A SURGICAL MICROSCOPE SNAPPED IN TWO AS REPRESENTATIVE WAS PREPARING THE EQUIPMENT FOR IN SERVICE TRAINING TO OPERATING ROOM PERSONNEL. THERE WERE NO INJURIES RELATED TO THE OCCURRENCE. ACCORDING TO THE SALES REPRESENTATIVE, WHEN THE SURGICAL MICROSCOPE ARRIVED AT THE HOSPITAL, REP REMOVED IT FROM THE SHIPPING (ROADIE) CASE AND PUSHED THE MICROSCOPE INTO THE OPERATING ROOM. THE SALES REPRESENTATIVE STATED THAT AT THIS POINT, REP WAS NOT AWARE OF THE STRESS FRACTURE ON THE INTERIOR SUPPORT BEAM. REP MENTIONED THAT THE FRACTURE WAS NOT NOTICED UNTIL REP REMOVED THE BRAKE USED TO STABILIZE THE COUNTERBALANCE WEIGHT SYSTEM. WHEN THE BRAKE WAS REMOVED AND THE MICROSCOPE ARM WAS EXTENDED, THE MAIN AND SECONDARY ARM OF THE MICROSCOPE FORCIBLY EXTENDED INTO A RIGID LOCKED EXTENSION POSITION. FOLLOWING THE EVENT, THE SALES REPRESENTATIVE INSPECTED THE INTERNAL SUPPORT BEAM OF THE MICROSCOPE AND OBSERVED THE STRESS FRACTURE. THERE WAS NO EVIDENCE OF DAMAGE TO THE MICROSCOPE EXTERIOR OR TO THE MICROSCOPE ROADIE CASE. BACKGROUND: THE OPERATION MICROSCOPE WAS DESIGNED FOR USE DURING NEUROSURGERY TO PROVIDE MAGNIFIED OBSERVATION OF SURGICAL SITES. IT IS APPROXIMATELY 6 FEET 8 INCHES TALL AND WEIGHS APPROXIMATELY 990 POUNDS. ACCORDING TO THE PRODUCT MANAGER FOR THE MICROSCOPE, PRIOR TO THIS RECENT EVENT, THREE ADDITIONAL MICROSCOPES SUSTAINED INTERIOR SUPPORT BEAM FRACTURES DURING SHIPPING. IN EACH CASE, THE MICROSCOPE WAS NOT BEING USED FOR PROCEDURES AND THERE WERE NO INJURIES RELATED TO THE OCCURRENCES. THE MANAGER STATED THAT TWO OF THE THREE MICROSCOPES WERE SHIPPED IN ROADIE CASES DESIGNED SPECIFICALLY FOR SHIPPING MICROSCOPES IN ONE PIECE. THE PRODUCT MANAGER MENTIONED THAT THE STEEL BRAKE, DESIGNED TO BE BOLTED DOWN UNDER THE TUNGSTEN COUNTERBALANCE WEIGHTS TO PROVIDE SUPPORT DURING SHIPMENT, WAS NOT IN USE WHEN TWO MICROSCOPES WERE SHIPPED. THIS IS CONTRARY TO TRAINING PROVIDED TO REPRESENTATIVES FOR TRANSPORT OF THIS PRODUCT. THE THIRD MICROSCOPE CLEARLY SUSTAINED SEVERE DAMAGE DURING SHIPPING DUE TO TRANSPORTATION CARRIER MISHANDLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SURGICAL MICROSCOPE EPT THE OLYMPUS OPTICAL CO. LTD. OME-8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN