MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Septic Shock (2068); Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

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 pre-stented, 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 intraparenchimatous 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 c22016417 is for urf-p5 and the reported adverse events.Patient identifier c22037271 is for urf-v and the reported adverse events.Patient identifier c22037272 is for urfv23000 (an unknown flexible ureteroscopy) and the reported adverse events.  this report is 2 of 3 for patient identifier c22037271 is for urf-v and the reported adverse events.

Manufacturer Narrative

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.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13472790
• MDR Text Key: 289605149
• Report Number: 8010047-2022-02504
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other