OR1 NEO IP, BAS-REM 3.1.2.12

Additional Manufacturer Narrative

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

Description of Event or Problem

ACCORDING TO THE INFORMATION RECEIVED, DURING A CASE IT WAS REPORTED THAT THE SYSTEM AND ALL MONITOR SIGNALS WENT OUT FOR ABOUT A MINUTE AND THEN CAME BACK ON. IT JUST HAPPENED AGAIN WHILE ON THE PHONE AND THE SCREENS TURNED PINK AND PURPLE BEFORE COMING BACK ON.