LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE

Description of Event or Problem

OLYMPUS WAS INFORMED BY THE STERILE PROCESSING MANAGER AT THE USER FACILITY THAT THE LIGHT-GUIDE CABLE WILL BE RETURNED FOR REPAIR FOR A REPORTED ¿CLOSE TO THE CONNECTOR THE OUTER COVERING CLOSE TO THE LIGHT FIBERS IS RIPPED¿ THAT WAS OBSERVED DURING REPROCESSING. THE DEVICE WAS RETURNED TO OLYMPUS; THE SERVICE EVALUATION FOUND THE OUTER PROTECTIVE COVER OF THE CABLE WAS TORN AND PULLED APART FROM THE LIGHT GUIDE ADAPTER SIDE WITH EXPOSED LIGHT FIBERS. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS.

Additional Manufacturer Narrative

THE SERVICE EVALUATION FOUND THE OUTER PROTECTIVE COVER OF THE CABLE WAS TORN AND PULLED APART FROM THE LIGHT GUIDE ADAPTER SIDE WITH EXPOSED LIGHT FIBERS. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDICAL DEVICE REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 1 YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE REPORTED ISSUE IS MOST LIKELY DUE TO A USER ERROR RESULTING FROM EXCESSIVE BUCKLING AND TENSILE LOAD. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.