CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR

Additional Manufacturer Narrative

THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE REPORTED COMPLAINT FOR THE TIP MISSING/BREAKING OFF THE DISTAL END OF THE DEVICE. THE DETACHED FRAGMENT WAS NOT RETURNED WITH THE ENDOSCOPE OBTURATOR. THE SIZE OF THE MISSING FRAGMENT IS APPROXIMATELY 25MM LENGTH, 6MM WIDTH, 4MM THICK AND SLIGHTLY ANGLED AT THE TIP. THE RETURNED DEVICE HAD SCRATCHES AND MINOR DENTS ALONG THE SHAFT AND A SLIGHT BEND AT THE DISTAL TIP. THIS TYPE OF DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. THE INSTRUCTIONS MANUAL CONTAINS SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT DAMAGE TO THE DEVICE. "UPON RECEIPT, EXAMINE THE INSTRUMENT AND ACCESSORIES FOR DAMAGE. DO NOT USE A DAMAGED PRODUCT. KEEP THE DISTAL TIP OF ANY ELECTRODE, PROBE, LASER FIBER, OR OTHER ANCILLARY DEVICE IN THE FIELD OF VIEW AT ALL TIMES WHEN ACTIVE. PRIOR TO EACH USE, EXAMINE ANY ELECTRODE OR OTHER ANCILLARY DEVICE/ACCESSORY AND ITS INSULATION FOR DAMAGE; DO NOT USE IF DAMAGED. EXAMINE THIS DEVICE PRIOR TO USE. DO NOT USE IF DAMAGE IS FOUND." IF ADDITIONAL INFORMATION OR IF THE MISSING FRAGMENT IS RECEIVED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

Description of Event or Problem

OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, IT WAS NOTICED THAT THE TIP WAS MISSING FROM THE DEVICE. THE PATIENT WAS EXAMINED USING A CT SCAN TO VERIFY IF THE TIP HAD FALLEN INSIDE THE PATIENT. THE CT SCAN RESULTS RETURNED NEGATIVE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.