OR1 NEO IP, BAS

Description of Event or Problem

ACCORDING TO THE INFORMATION RECEIVED, TC304 FAILED DURING PROCEDURE, IMAGE CUT IN AND OUT DUE TO THE PRONGS BEING DAMAGED. COULD NOT TAKE PICTURES DUE TO AIDA IN FIBERS NOT COMMUNICATING. USED ANOTHER ROOM, PROVIDED A SECONDARY MONITOR AND TOWER TO STAY IN THE SAME ROOM BUT SURGEON WANTED TO MOVE. SURGEON WAS ABLE TO COMPLETE PROCEDURE IN ANOTHER ROOM. THERE WAS NO HARM TO THE PATIENT.

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. THEREFORE, AN IMPORTER IS NOT REQUIRED FOR THIS EVENT.