OR1 FLEXRACK, PS16B, NEO IP

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, THE UPS SPARKED AND CAUGHT ON FIRE DURING CASE. LOST INTEGRATION VIDEO, MOBILE TOWER WAS ROLLED IN TO COMPLETE CASE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.