Olympus was informed of the following literature article: "complications after 4,500 flexible ureteroscopy (academic single center experience)" by bf geavlete, r multescu, c ene, c bulai, pa geavlete.The aim of this study was to evaluate the indications, limits and efficacy of flexible ureteroscopy on a significant number of cases and on a long follow-up period.Overall complications occurred in 18.9% of the procedures.During the diagnostic procedures inspection of the entire upper urinary tract was possible in 90% of the cases (2,700 patients).Stone free rate in lithiasis cases was 93.3% after one procedure, 95.2% after the second and 97.3% after the third one.The study concluded that retrograde flexible ureteroscopic approach was an efficient diagnostic and treatment method for renal pathology.Also the complication rate is relatively reduced, but a serious training is indicated before using this device.The surgeons used the following olympus devices in the procedures: olympus urf-p5, olympus urf-v, olympus urf-v23000.The authors did no specify which device was used on a specific patient with adverse events.Therefore, the adverse events will be reported for each olympus device.Adverse events: septic complications (ranging from fever to septic shock) occurred in 12.1% of the cases, most of them being mild.(12.1% of procedures).51.9% of the septic patients were presented, and only 25% of them were operated using a ureteral access sheath.69% of cases had complications that were clavien ii complications.16% of cases had complications that were clavien iia complications.10% of cases had complications that were clavien iva complications.5% of cases had complications that were clavien ivb complications.6.8% severe upper urinary tract wall lesions, postoperative pain, persistent hematuria, liquid retroperitoneal extravasation, intrarenal or subcapsular hematoma).5 cases of intraparenchymatous postop.17 case of subcapsular hematoma postop.3 cases presented massive liquid extravasation of the fluid in the retroperitoneum.4.8% of the cases we encountered grade 2 and 3 ureteral wall injuries when using the ureteral access sheath.Patient identifier (b)(6) is for urf-p5 and the reported adverse events.Patient identifier (b)(6) is for urf-v and the reported adverse events.Patient identifier (b)(6) is for an unknown flexible ureteroscopy and the reported adverse events.This report is 3 of 3 for an unknown flexible ureteroscope.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the possibility of an adverse event occurring with the subject device is uncertain because there is no evidence that it occurred with an olympus product.The purpose of this study was to evaluate the indications, limitations, and efficacy of flexible ureteroscopy in a significant number of cases and a long follow-up period.The study concluded that a retrograde flexible ureteroscopy approach is an efficient method of diagnosis and treatment of renal lesions.No product-related deficiencies were noted in the literature; there was no explanation on device malfunction.Olympus will continue to monitor field performance for this device.
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