UNKNOWN
Received Sep 14, 2022
Report 9610595-2022-01823 · MDR key 15422245
Device
Product problems
- Communication or Transmission Problem
- Communication or Transmission Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PATIENT IDENTIFIER : (B)(6). RELATED PATIENT IDENTIFIER: (B)(6) (ADDRESSES THE CV-190 - EVIS EXERA III VIDEO SYSTEM CENTER. IN SPEAKING WITH OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER REPORTED THERE WAS A B30 ERROR AND AN E216 ERROR. CUSTOMER REPORTED THE ISSUE OCCURS WILL ALL PROCESSORS. TAC EXPLAINED THE ISSUE IS WITH THE SCOPES AND ADVISED CUSTOMER TO SEND IN SCOPES FOR EVALUATION. THE CUSTOMER ENDED THE CALL AFTER TAC PROVIDED A RESPONSE BUT BEFORE TAC COULD OBTAIN IDENTIFYING INFORMATION FOR THE USER FACILITY OR DEVICES INVOLVED. THE INVESTIGATION IS ONGOING AND FOLLOW UP ATTEMPTS WERE MADE TO THE CUSTOMER, BUT WERE NOT SUCCESSFUL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.
Description of Event or Problem
THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THERE WAS A B30 COMMUNICATION ERROR AND AN E216 ERROR WHEN USING AN EVIS EXERA III VIDEO SYSTEM CENTER AND UNKNOWN SCOPE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.