MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V2

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

Patient Problems Urinary Tract Infection (2120); Renal Impairment (4499)

Event Date 11/15/2023

Event Type  Injury  

Event Description

Olympus reviewed the literature titled "treatment outcome on urolithiasis with urinary tract malformation at osaka rosai hospital." objective: to evaluate treatment outcome on urolithiasis with urinary tract malformation.Materials and methods: fifteen patients from 2012 to 2021.Stone free (sf) is defined as 4mm or less.Hydronephrosis and impacted stones were excluded.Results: stones of 6 and 9 cases with urinary tract malformation were located in the kidney (1 calyceal diverticular calculi, 1 parapelvic renal cyst and 4 pelvic-ureteric junction obstruction) and the ureter (3 incomplete duplex kidneys, 5 ureteral strictures and 1 ileal neobladder), respectively.Overall, 10, 6, 6, 6 and 5 were not able to preoperatively diagnose, access the stone at initial treatment, finish only retrograde approach, complete in one treatment, and avoid complications, respectively.Finally, sf was achieved in 10 cases.Conclusions: it is often difficult to treat urolithiasis with urinary tract malformation in the urinary tract.Type of adverse events/number of patients urinary tract infection -3 renal dysfunction (due to ureteral stricture) -1 urinary tract infection and renal dysfunction (due to pelvic-ureteral junction stricture) -1.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.And to provide information received through follow-up (b5).The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information was received from the author: an olympus device did not cause or contribute to the adverse event described in the article.Also, it was confirmed that an olympus device malfunction did not occur.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18666607
• MDR Text Key: 334835999
• Report Number: 9610595-2024-02729
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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-V2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/23/2024
• 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: BASKET (MEDICON BIRD SKYLITE).; LASER (LUMENIS VERSA PULSE).; NAVIGATOR HD BOSTON SCIENTIFIC.; RIGID PYELOSCOPE UNIVERSAL NEPHROSCOPE 24FR.; RIGID URETEROSCOPE 8.0/9.8FR RICHARD WOLF.
• Patient Outcome(s): Other