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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

THE CUSTOMER REPORTED TO OLYMPUS, THE GRASPING FORCEPS PACKAGING WOULD RIP AND TEAR ON THE PLASTIC SIDE AND CONTAMINATE THE INNER ITEM RENDERING IT UNUSABLE. THE ISSUE WAS FOUND DURING A THERAPEUTIC UROLOGY PROCEDURE. THE PROCEDURE WAS HINDERED BY HAVING TO OPEN ANOTHER GRASPER. THERE WERE NO REPORTS OF PATIENT HARM.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.