UNKNOWN

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION. THE DEVICE HISTORY RECORDS (DHR) REVIEW COULD NOT BE PERFORMED BECAUSE A SERIAL NUMBER WAS NOT PROVIDED. OLYMPUS SHIPS DEVICES THAT MEET ALL APPLICABLE PROCEDURES AND MEET FINAL PRODUCT RELEASE CRITERIA. THE MODEL NUMBER WAS NOT PROVIDED BY THE CUSTOMER. A HISTORICAL DATA ANALYSIS AND TREND ANALYSIS COULD NOT BE PERFORMED. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE LEGAL MANUFACTURER DETERMINED THE PROBABLE CAUSE OF THE FAILURE IS UNABLE TO BE DETERMINED.

Additional Manufacturer Narrative

THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. ALTHOUGH THE SUBJECT DEVICE MODEL CANNOT BE CONFIRMED, IT IS LIKELY TO BE A FLEXIBLE ENDOSCOPE. THE CUSTOMER REFUSES TO PROVIDE ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS. THIS EVENT HAS BEEN SUBMITTED BY THE IMPORTER ON MDR# 2951238-2021-00435. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

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.