In the literature titled "flexible ureterorenoscopy with holmium laser lithotripsy for upper urinary urolithiasis.", it is reported patients experienced adverse effects during and after procedures using uretero-reno fiberscopes urf-p6 or urf-p6r.Case with patient identifier (b)(6) reports urf-p6r.Case with patient identifier (b)(6) reports urf-p6.Study aim: to provide a brief overview of one facility¿s experience with ureterorenoscopy for treating upper urinary tract stones including success and complication of this procedure.Method: retrospective review of 93 patients undergoing ureterorenoscopy with holmium laser lithotripsy for renal and proximal ureteral stones using an olympus flexible ureteroscope (either urf-p6 or urf-p6r).Results: study included 93 patients (57 males and 36 females) with a mean age of 50.There were no major ureteral injuries.Mucosal abrasions were noted in four patients and were managed successfully with stent placement.All adverse events were classified with the clavien dindo grading system.Grade one complications were observed in nine patients (moderate pain).Grade two complications were observed in 17 patients (fever, severe pain, and postoperative obstruction).Conclusion: flexible ureteroscopy can be safely used to treat renal and proximal ureteral stones with a low rate of complications.
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.No device was sent for evaluation, and a serial number was not provided.Complaint information provided the basis of this investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the investigation, a definitive root cause could not be established.The case was a study that aimed to ¿provide a brief overview of their experience with ureterorenoscopy for treating upper urinary tract stones, including success and complications of this treatment¿.Since the device was not sent to olympus, the device was not analyzed.As no device was alleged with default with this report, no cause was deemed applicable - ergo, no device problem was identified.Olympus will continue to monitor field performance for this device.
|