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

Model Number URF-P6R

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

Patient Problems Abrasion (1689); Fever (1858); Pain (1994); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final 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, no abnormality or problem with the device has been reported, therefore the cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• 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: 13486690
• MDR Text Key: 287034317
• Report Number: 8010047-2022-02613
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340833
• UDI-Public: 04953170340833
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

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-P6R
• 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: 02/08/2022
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 03/03/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other