SINGLE USE RETRIEVAL BASKET V

Additional Manufacturer Narrative

THE SUBJECT DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THEREFORE THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

Description of Event or Problem

WE RECEIVED THE FOLLOWING REPORT. DURING AN ENDOSCOPIC REMOVAL OF A LARGE STONE (CONCRETION), THE SUBJECT DEVICE WAS USED. THE SUBJECT DEVICE COULD NOT BE REMOVED FROM THE PATIENT BODY. THE USER USED THE EMERGENCY LITHOTRIPTOR, BUT THE USER COULD NOT REMOVE THE SUBJECT DEVICE SINCE THE BASKET WIRE WAS NOT BROKEN OFF, BUT THE OPERATING WIRE WAS BROKEN OFF AT THE PROXIMAL SIDE. THE PATIENT WAS INTUBATED UNTIL THE FOLLOWING DAY AND THE STONE WAS REMOVED WITHOUT FURTHER CONSEQUENCES. THIS IS THE REPORT REGARDING THE FAILURE OF THE DEVICE'S REMOVAL.

Additional Manufacturer Narrative

THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE BROKEN WIRE WAS SENT BACK FOR THE EVALUATION. THE LENGTH OF THE BROKEN WIRE IS 970MM. DUCTILE FAILURE WAS FOUND AT THE DISTAL END OF THE OPERATION WIRE. A PULLING LOAD WAS APPLIED TO THE OPERATION WIRE. THAT HAVE CAUSED THE DUCTILE FAILURE. THE OUTER DIAMETER OF THE OPERATION WIRE WAS MEASURED. THERE WAS NO ABNORMALITY FOUND. THE LOT NUMBER OF THE SUBJECT DEVICE IS UNKNOWN. AS A RESULT OF CHECKING THE MANUFACTURING RECORD FOR PAST ONE YEAR FROM THE DELIVERY DATE, IT WAS FOUND NO IRREGULARITIES. AN EXCESSIVE LOAD BEYOND THE STRENGTH LIMIT WAS APPLIED TO THE PRODUCT WHEN CRUSHING AN ENLARGED CALCULUS BY USING THE LITHOTRIPTER. THAT MIGHT HAVE CAUSED THE OPERATION WIRE TO BREAK. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.