GRASPING FORCEPS

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. NEW INFORMATION ADDED TO THE FOLLOWING FIELDS: D8, H3, AND H6. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, OLYMPUS CONFIRMED FOREIGN MATERIAL ADHERED INSIDE THE BASKET WIRE PORTION AND TUBE SHEATH AT 31 CM FROM ITS DISTAL END, BUT THE TYPE OF THE MATERIAL OR ROOT CAUSE CANNOT BE IDENTIFIED. HOWEVER, IT IS LIKELY THE DEVICE WAS NOT IMMERSED IN DETERGENT SOLUTION IMMEDIATELY AFTER USE AND/OR THE CLEANING SOLUTION WAS NOT INJECTED INTO THE INSERTION PORTION IMMEDIATELY AFTER USE. REGARDING THE TUBE SHEATH WAS BUCKLED, ALTHOUGH THE ROOT CAUSE COULD NOT BE IDENTIFIED, IT IS LIKELY REPEATED CALCULUS RETRIEVAL CAUSED THE DEVICE TO DETERIORATE, THE GRASPING PORTION WAS OPENED AND CLOSED IN A STATE WHERE IT WAS DIFFICULT TO OPEN AND CLOSE IN THE REPROCESSING, AND THE INSERTION PORTION WAS FORCEFULLY SQUEEZED, WIPED OR SCRUBBED IN THE REPROCESSING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "DRAWING NUMBER: GW8868, REVISION NUMBER: 24. ¿ THIS INSTRUMENT WILL DEFORM AND/OR DETERIORATE BY PERFORMING CALCULUS RETRIEVAL. REPETITION OF CALCULUS RETRIEVAL WILL EXTEND THE EFFECT. BY SUCH DEFORMATION AND/OR DETERIORATION, CALCULUS MAY NOT BE RETRIEVED AND/OR THE BASKET WITH CALCULUS ENGAGED MAY NOT BE REMOVED FROM THE BODY. IF CALCULUS RETRIEVAL NEEDS TO BE REPEATED IN A SINGLE CASE, MAKE SURE TO CHECK THE ACTION AND THE APPEARANCE EACH TIME THAT NO ABNORMALITY IS DETECTED (E.G. BASKET WIRE CUT OR WORN, TUBE SHEATH BENT ETC.). STOP USE WHEN ANY ABNORMALITY IS DETECTED. ¿ DURING CALCULUS RETRIEVAL, KEEP THE PORTION FROM THE TUBE SHEATH TO THE HANDLE STRAIGHT IN LINE WITH THE SCOPE¿S BIOPSY VALVE, AS MUCH AS POSSIBLE. IF NOT STRAIGHT, THE TUBE SHEATH MAY BEND, CALCULUS MAY NOT BE RETRIEVAL, AND/OR THE GRASPING BASKET WITH CALCULUS ENGAGED MAY NOT BE REMOVED FROM THE BODY. ¿ WHEN REPROCESSING, DO NOT COIL THE INSERTION PORTION WITH A DIAMETER OF LESS THAN 15 CM. THIS COULD RESULT IN DAMAGE TO THE INSERTION PORTION. ¿ NEVER USE EXCESSIVE FORCE TO OPEN OR CLOSE THE INSTRUMENT. THIS COULD RESULT IN DAMAGE TO THE INSTRUMENT. ¿ IMMERSE THE INSTRUMENT AND FG HANDLE IN DETERGENT SOLUTION IMMEDIATELY AFTER USE. IF THE INSTRUMENT OR FG HANDLE IS NOT CLEANED IMMEDIATELY, IT MAY BE DIFFICULT TO EFFECTIVELY REPROCESS, AND THIS COULD RESULT IN REDUCED PERFORMANCE. ¿ DO NOT FORCEFULLY SQUEEZE, WIPE OR SCRUB THE INSTRUMENT. THIS COULD CAUSE DAMAGE TO THE INSTRUMENT OR RESULT IN REDUCED PERFORMANCE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A PRESENCE OF RESIDUES (BLOOD, MUCUS) IN THE GRASPING FORCEPS BASKET SLEEVE AFTER USE THAT COULD NOT BE PROPERLY CLEANED DURING AND AFTER USE SOAK. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.