SINGLE USE GRASPING FORCEPS FG-253SX

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. PLEASE SEE UPDATES TO B3 OF THE INITIAL MEDWATCH. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, THE VISUAL INSPECTION OF THE PHYSICAL DEVICE UNDER A MICROSCOPE FOUND NO BIOMATERIAL OR DEBRIS ON THE DISTAL END. THE COIL SHEATH IS UNIFORM, AND HANDLE IS INTACT. ADDITIONALLY, THE ROTATION GRIP COULD ROTATE THE DISTAL END CLOCKWISE, AND THE SLIDER WAS ABLE TO OPEN AND CLOSE THE JAWS WITHOUT AN ISSUE. 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, THE REPORTED COMPLAINT COULD NOT BE DETERMINED DUE TO PACKAGING WAS DISCARDED DURING DECONTAMINATION PROCESS. HOWEVER, THE DEVICE IS FUNCTIONAL AND IN GOOD CONDITION. FURTHERMORE, THE LIKELY CAUSE OF THE REPORTED EVENT IS DUE TO THE STERILE PACKAGES THAT ARE ADDITIONALLY HEAT-SEALED HAVE A HIGHER SEAL STRENGTH THAN THOSE THAT ARE NOT ADDITIONALLY HEAT-SEALED. THEREFORE, THE STERILE PACKAGES WITH ADDITIONAL HEAT SEALING ARE DIFFICULT TO OPEN WHICH MAY HAVE CAUSED THE REPORTED EVENT. HOWEVER, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) WHICH STATE: ·DO NOT STORE THE STERILE PACKAGES CONTAINING THE INSTRUMENT IN PLACES WHERE THEY WILL BE DAMAGED, WET, OR IMPROPERLY SEALED. OTHERWISE, THE STERILITY OF THE INSTRUMENT MAY BE COMPROMISED AND POSE AN INFECTION CONTROL RISK OR CAUSE TISSUE IRRITATION. ·DO NOT USE AN INSTRUMENT IF IT IS DROPPED BEFORE THE CARTON OR THE PACKAGE IS OPENED. IF THE STERILIZED PACK IS DAMAGED, THE STERILITY MAY BE COMPROMISED. ·ALWAYS HAVE A SPARE INSTRUMENT AVAILABLE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC REMOVAL OF URETERAL STENT PROCEDURE THE SINGLE USE GRASPING FORCEPS DID NOT COME OUT OF THE PACKAGE AND REMAINED STERILE. THE PLASTIC SIDE OF THE PACKAGE RIPPED AND TORN AND CONTAMINATED THE INNER ITEM, RENDERING IT UNUSABLE. STAFF REPORTED THAT THAT HAD BEEN HAPPENING MORE THAN THESE TWO TIMES. THE PROCEDURE WAS COMPLETED, BUT IT WAS SLOWED DOWN BY HAVING TO OPEN A NEW GRASPER. THERE WAS NO REPORT ON PATIENT HARM ASSOCIATED WITH THE EVENT. CUSTOMER DID NOT HAVE ANY OTHER PACKAGING. THOSE DISPOSABLE GRASPERS WERE THE ONLY OPTION CUSTOMER WAS HAVING FOR REMOVING/CHANGING URETERAL STENTS. CUSTOMER HAD THOSE 2 UNUSABLE ONES DUE TO POOR/DEFECTIVE PACKAGING. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6).

Additional Manufacturer Narrative

TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.