FLEX-CATCH 4 WIRE NITINOL BASKET

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SCHEDULED PROCEDURE FOR THERAPEUTIC, TRANSURETHRAL URETEROLITHOTOMY PROCEDURE, A NEPHROLITHOTOMY UNDER GENERAL ANESTHESIA, WHEN ATTEMPTING TO BREAK DOWN THE STONE, THE STONE ENTERED THE BASKET, AND THE BASKET BECAME UNABLE TO MOVE. THE STAFF WAS UNABLE TO EITHER REMOVE OR CLOSE THE BASKET. ALSO, ATTEMPTED TO DISASSEMBLE THE PRODUCT, BUT THE BASKET COULD NOT BE REMOVED IN THE RENAL CALYX. SUBSEQUENTLY, BASED ON THE PHYSICIAN'S JUDGMENT, THE ROOT OF THE BASKET WAS INTENTIONALLY CUT WITH A LASER, BUT THE BASKET REMAINED INSIDE THE BODY. THE BASKET REMAINING INSIDE THE BODY WAS RETRIEVED USING GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. REPORTEDLY, NO PARTICULAR PROBLEMS OCCURRED SINCE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THE REPORTED EVENT MAY HAVE OCCURRED BECAUSE DEFORMATION AT THE SHEATH'S BASE, THE CONTROL UNIT END OBSTRUCTED THE WIRE MOVEMENT REQUIRED TO PULL IN OR OPEN THE BASKET. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.