OR1 NEO IP, ENH2

Description of Event or Problem

IT HAS BEEN REPORTED THAT THE INSTALL ON THIS ROOM LAST WEEK AND ALL THREE VIDEO PLATES ON THE MONITOR ARM ARE NOT PASSING A SIGNAL TO THE NEW IP. IT OCCURED DURING A PROCEDURE WITH NO PATIENT IMPACT. A SECONDARY NON-NETWORKS VIDEO DEVICES HAD TO BE MOVED INTO THE OR TO COMPLETE THE PROCEDURE. FORTUNATELY, IT WAS IN AN INTERVENTIONAL SUITE WHERE THE INTERVENTIONAL IMAGE WAS NOT INTERRUPTED INDEPENDENT FROM OUR SYSTEM. THE NAVIGATION MONITOR HAD TO BE MOVED OVER AS THE CATHETER WAS IN THE PATIENT DURING THE PROCEDURE IN ORDER FOR THE PHYSICIAN TO SEE AT LOCATION WHERE HE WAS RELYING ON OUR MONITOR NARRATION TO NAVIGATE.

Additional Manufacturer Narrative

THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Additional Manufacturer Narrative

CORRECTIONS MADE IN SECTIONS: D2B, D4, E1, G4, AND H11. THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. RATHER, THEY WILL SEND A 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 EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Additional Manufacturer Narrative

THIS PRODUCT IS MANUFACTURED AT KARL STORZ ENDOSCOPY AMERICA, 13803 N PROMENADE BLVD, STAFFORD, TX 77477; HOWEVER, IT IS DESIGNED IN GERMANY. DEVICE EVALUATION: DEFECTIVE FIBER TERMINATION AT NETWORK SWITCH AND POTENTIAL POWER INSTABILITY FROM FAULTY UPS UNIT (POWERVAR THIRD-PARTY DEVICE). BOTH ISSUES CONTRIBUTED INTERMITTENT SIGNAL LOSS ON VIDEO PLATES. THE ISSUE WAS RESOLVED BY FIXING THE FIBER TERMINATION, REPLACING THE UPS, AND BOTH VIDEO PLATES. NO FURTHER ISSUES NOTED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).