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 Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Urethral Stenosis/Stricture (4501)

Event Type  Injury  

Event Description

Olympus reviewed the following literature aritlce: "endoscopic management of upper urinary tract urothelial carcinoma: oncologic outcomes and prognostic factors in a contemporary cohort" by francesco sanguedolce, md et al.  the study aimed to identify risk factors associated to tumor recurrence and progression in a contemporary cohort of patients diagnosed and treated with the latest endourologic technologies.Median follow-up (fu) was 24 months (interquartile range 17¿44).On multivariate analysis, bladder cancer (bc) recurrence was associated to previous contralateral utuc (hazard ratios: 5.08 confidence interval [95% ci: 1.35¿18.94], p < 0.05) and tumor size (hazard ratios: 1.07 [95% ci: 1.00¿1.14], p < 0.05).Utuc recurrence was associated to incomplete clearance after primary treatment (hazard ratios: 4.99 [95% ci: 1.15¿ 21.62], p < 0.05), while utuc progression was significantly related to the number of utuc recurrences (hazard ratios: 3.10 [95% ci: 1.27¿7.53], p < 0.05).No significant survival differences in bc/utuc recurrence, as well as in utuc progression, were detected between risk groups.No clavien-dindo grade >2 were detected; one patient developed ureteric stricture at 7-month fu.The appropriate use of latest technology may enhance the oncologic outcomes of the endoscopic management of utuc without compromising the safety of the approach.Among the prognostic factors identified in the series, utuc recurrence seems to be associated to disease progression.  self-limiting bleeding (clavien-dindo grade ii) - 4.Infectious complications - 3.Major bleeding requiring blood transfusion - 1.Ureteric stricture in the lumbar tract - 1.  since the literature described "urf-v, narrow band imaging ", we selected "urf-v" as a representative product.

Manufacturer Narrative

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

• 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: 13483389
• MDR Text Key: 289960175
• Report Number: 8010047-2022-02581
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2022

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: 02/08/2022
• 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): Other; Required Intervention