UNKNOWN
Received Oct 29, 2021
Report 2951238-2021-00435 · MDR key 12720364
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED TO THE OLYMPUS EMPLOYEE THERE IS A PATIENT INFECTION FOLLOWING THE USE AN UNKNOWN OLYMPUS SCOPE. THE CUSTOMER STATES THE AUTOMATED ENDOSCOPE LEAK TESTER DID NOT DETECT A LEAK ON THE SCOPE USED WITH THE PATIENT. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. IT IS UNKNOWN IF THE LEAK TESTER AND/OR IF THE SCOPE IS RELATED TO THE PATIENT INFECTION. THEREFORE, BOTH ARE BEING SUBMITTED. PATIENT IDENTIFIER (B)(6) IS FOR THE PATIENT INFECTION WITH THE LEAK TESTER. PATIENT IDENTIFIER (B)(6) IS FOR THE PATIENT INFECTION AND THE SCOPE INVOLVED. THIS REPORT IS COMPLAINT 2 OF 2 FOR PATIENT IDENTIFIER (B)(6) IS FOR THE PATIENT INFECTION AND THE SCOPE INVOLVED. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.