CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR
Received Aug 13, 2020
Report 1519132-2020-00051 · MDR key 10405568
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED. DURING A VISUAL INSPECTION OF THE DEVICE IT WAS OBSERVED THAT THE TIP WAS BROKEN AND MISSING. THE PROBABLE CAUSE COULD BE DUE TO THE TIP COMING IN CONTACT WITH A HARD OBJECT. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS PROVIDED A SUPPLEMENTAL REPORT WILL BE FILED. 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.
Description of Event or Problem
A USER FACILITY REPORTED THAT THE TIP OF THE OBTURATOR SCOPE IS BROKEN OFF AND MISSING. THE DETACHED FRAGMENT WAS NOT RETURNED WITH THE ENDOSCOPE OBTURATOR. THE ISSUE WAS FOUND DURING REPROCESSING. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.