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

Model Number URF-P6

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

Patient Problems Fever (1858); Pain (1994); Hematuria (2558); Unspecified Kidney or Urinary Problem (4503)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The legal manufacturer's investigation is completed.The literature article is attached for additional information.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

Event Description

Olympus reviewed the following literature "efficacy of one-surgeon basketing technique for stone extraction during flexible ureteroscopy for urolithiasis."     literature summary: this study evaluated the safety and efficacy of using one-surgeon basketing technique by a solo surgeon for stone extraction during flexible ureteroscopy (f-urs) for urolithiasis.Among our study population, the median stone size was 14 mm and median operative time was 74 min.A stone-free status was achieved in 91 patients (91%).The median stone fragmentation time was 15 min and stone retrieval time was 30 min.All included patients were treated using the one-surgeon basketing technique.Complications related to stone retrieval were identified in two patients (2%); the degree of ureteral injury was classified as clavien¿dindo grade iiia.The one-surgeon basketing technique is safe and effective for the extraction of stone fragments during f-urs for urolithiasis.This technique does not require assistance for basketing; therefore, f-urs with active retrieval basketing can be completed by a solo surgeon.Type of adverse events/number of patients: stone-related pain 2 patients.Macrohaematuria 2 patients.Ureteral injury 5 patients.Postoperative fever 5 patients.Additional information was requested from the author.The serial number for the subject device is unknown.The ureteral injury was also minor and was conservatively improved, requiring no additional treatment.And in the opinion of the author, the subject device did not cause or contribute to the adverse events in the study. .

• 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: 14713705
• MDR Text Key: 294389907
• Report Number: 8010047-2022-10159
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2022

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-P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/16/2022
• 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
• Treatment: NON-OLYMPUS DEVICES: BASKET AND ACCESSORIES,; NON-OLYMPUS:GARNET LASER, IRRIGATION SYSTEM.
• Patient Outcome(s): Other