OES CHOLEDOCHO FIBERSCOPE
Received Oct 9, 2021
Report 8010047-2021-12945 · MDR key 12602550
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO SORC. SORC CHECKED THE SUBJECT DEVICE AND FOUND THE REPORTED PHENOMENON. OMSC REVIEWED THE MANUFACTURE HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. BASED UPON THE INFORMATION FROM SORC THAT SORC FOUND THE PIN HOLE ON THE BENDING RUBBER DURING THE INSPECTION, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE ACTION FAILURE OF THE ANGULATION DUE TO THE CORROSION OF THE WIRE AND/OR THE BENDING SECTION WHICH MIGHT BE CAUSED BY THE WATER INGRESS FROM THE PIN HOLE ON THE BENDING RUBBER. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED
Description of Event or Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER (SORC), IT WAS FOUND THAT THE ANGULATION WAS LOCKED DUE TO CORROSION OF THE ANGULATION MECHANISM. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.