PROVIDO

Additional Manufacturer Narrative

THIS IS A FINAL REPORT. NO PARTS WERE RETURNED FOR EXAMINATION AS THE AFFECTED POWER CABLE WAS SCRAPPED LOCALLY. THE INVESTIGATION WAS THEREFORE BASED ON INFORMATION PROVIDED BY THE CUSTOMER AND THE LEICA FIELD SERVICE ENGINEER WHO INSPECTED THE AFFECTED UNIT ON-SITE. THE FIELD SERVICE ENGINEER IDENTIFIED THAT THE OUTER SHEATH OF THE POWER CABLE WAS DAMAGED AT A SINGLE POINT, EXPOSING THE INNER CONDUCTOR. THE DAMAGE WAS LIKELY CAUSED BY AN EXTERNAL MECHANICAL STRESS, SUCH AS THE WHEEL FROM ANOTHER DEVICE FOR EXAMPLE OR A SIMILAR EXTERNAL FORCE. AT THE TIME OF THE INCIDENT, THERE WAS WATER ON THE OPERATING ROOM FLOOR. DUE TO THE DAMAGED CABLE INSULATION, WATER PENETRATED THE DAMAGED SECTION OF THE POWER CABLE AND CAUSED A SHORT CIRCUIT. THIS SHORT CIRCUIT ACTIVATED THE OPERATING ROOM'S POWER SUPPLY OVERCURRENT PROTECTION, CAUSING AN IMMEDIATE INTERRUPTION OF ELECTRICAL POWER TO THE SURGICAL MICROSCOPE. THE DEVICE SWITCHED OFF ABRUPTLY DUE TO LOSS OF POWER. NO MALFUNCTION OF INTERNAL SYSTEM COMPONENTS WAS IDENTIFIED; THE SHUTDOWN WAS A CONSEQUENCE OF EXTERNAL SHORT CIRCUIT CONDITIONS AT THE POWER CABLE. THE EVIDENCE INDICATES THAT THE INCIDENT WAS CAUSED BY EXTERNAL MECHANICAL DAMAGE TO THE POWER CORD IN COMBINATION WITH ENVIRONMENTAL CONDITIONS. THE EVENT IS THEREFORE ATTRIBUTED TO EXTERNAL INFLUENCES RATHER THAN A DEFECT OF THE SURGICAL MICROSCOPE. THE DAMAGED POWER CABLE WAS REPLACED. AFTER THE REPLACEMENT AND FUNCTIONAL TESTING, THE DEVICE OPERATED NORMALLY.

Additional Manufacturer Narrative

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

Description of Event or Problem

LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM CHINA STATING THAT A PROVIDO HAD A LOSS OF POWER DURING A SURGICAL PROCEDURE. THERE WAS NO PATIENT/USER INJURY.