OR1 NEO IP, ENH

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. RATHER, WE WILL SEND OUR SERVICE TECH TO EVALUATE THE DEVICE IN THE FIELD. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS PRODUCT IS MANUFACTURED AT KARL STORZ ENDOSCOPY AMERICA, 13803 N PROMENADE BLVD, STAFFORD, TX 77477; HOWEVER, IT IS DESIGNED IN GERMANY. THEREFORE, AN IMPORTER IS NOT REQUIRED FOR THIS EVENT. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE OPERATING ROOM WENT DOWN BECAUSE THE UNIVERSAL POWER SUPPLY (UPS) IN THE ROOM FAILED, CASE WAS ABOUT TO START, AND THE SYSTEM WENT DOWN CAUSING THEM TO MOVE THE PATIENT TO ANOTHER ROOM TO CONTINUE. THIS CAUSED A DELAY TO THE CASE, WHICH CAUSED ISSUES WITH PATIENT BLOOD SUPPLY TO OVARIES.

Additional Manufacturer Narrative

PER THE EVALUATION CONDUCTED IN THE FIELD: INITIAL OBSERVATIONS: SYSTEM EXPERIENCED COMPLETE SIGNAL AND POWER LOSS MID-PROCEDURE. BIOMED REPORTED CORRODED BATTERY LEADS AND NON-OEM REPLACEMENT BATTERIES INSTALLED IN THE POWERVAR UPS. THE UPS BATTERY INDICATOR INITIALLY SHOWED EMPTY, BUT PHYSICAL REMOVAL/REINSERTION TRIGGERED INCONSISTENT READINGS AND AUDIBLE ALERTS. THE ISSUE COULD BE REPRODUCED BY MANUALLY MOVING THE BATTERY, CONFIRMING UNSTABLE ELECTRICAL CONNECTION AT CORRODED LEADS. FIELD FINDINGS: BIOMED AND SALES REPRESENTATIVE JOINTLY INSPECTED THE UPS; CONFIRMED LEAD CORROSION AND BATTERY TERMINAL INSTABILITY. REPLACED THE BATTERY AND ASSOCIATED LEADS; CONFIRMED THAT THE NEW SETUP RESTORED STABLE POWER CONTINUITY. VERIFIED THAT AFTER REPLACEMENT, SYSTEM POWERED ON NORMALLY AND VIDEO ROUTING RESUMED WITH NO RECURRENCE. IDENTIFIED NO ELECTRICAL FAULTS IN THE NEO IP CONTROLLER OR INTEGRATION NETWORK; FAULT ISOLATED TO UPS ASSEMBLY THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Additional Manufacturer Narrative

CORRECTION MADE IN SECTION B2. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).