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

Model Number	URF-P7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Kidney or Urinary Problem (4503); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) reviewed a literature titled "predictive factors for prolonged operative time in ureteroscopic lithotripsy for ureteral stones".Literature summary introduction: a prolonged operative time of lithotripsy with ureteroscopy for urolithiasis increases the risk of infectious complications; however, few reports have investigated the factors prolonging the operative time for ureteral stones.We investigated the factors associated with longer operative time in ureteroscopy for ureteral stones.Methods: this retrospective cohort study analyzed patients who underwent retrograde ureteroscopic lithotripsy for ureteral stones and achieved an endoscopic stone-free status between april 2019 and july 2022.Patients were classified into two groups based on an operative time of =90 minutes or <90 minutes.We compared the patient and stone characteristics and surgical outcomes, and investigated the factors associated with a prolonged operative time.Results: the cohort comprised 519 patients, with 58 patients in the group with an operative time of =90 minutes.Compared to the shorter operative time group, the longer operative time group had a significantly greater proportion of males, stone diameter, stone volume, and hounsfield units of stone; additionally, the longer operative time group had higher prevalences of endoscopic findings of edema, polyps, and mucosa-stone adherence.Multivariable analysis showed that stone size >10 mm (odds ratio 4.05), polyps (odds ratio 2.40), and mucosal adherence (odds ratio 3.51) were significantly associated with an operative time exceeding 90 minutes.There were no significant differences between the two groups in the incidences of postoperative fever and systemic inflammatory response syndrome.Conclusions: stone size, endoscopic findings of polyps, and mucosa-stone adherence were independent factors associated with a longer operative time.Type of serious adverse events/number of patients sirs (systematic inflammatory response syndrome) (48 patients) ureteral injury (20 patients).
Additional Manufacturer Narrative
H6 health effect - clinical code 4581 - appropriate term / code not available is used to reflect sirs (systematic inflammatory response syndrome) h6 health effect - clinical code 4503 - unspecified kidney or urinary problem is used to reflect ureteral injury the evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide an update to field (d8) and to provide a correction to field (d4).Since the serial and/or lot number was not provided, the (udi) unique device identifier is unknown and have been left blank accordingly.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 reported event was likely an accident, or a complication associated with a surgical procedure while using the subject device.There was no complaint reported on the subject device and no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Common Device Name: URETERO-RENO FIBERSCOPE
• 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: 20588031
• Report Number: 9610595-2024-22448
• Device Sequence Number: 8804699
• Product Code: FGB
• UDI-Device Identifier: 04953170435096
• UDI-Public: 04953170435096
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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
• Operator of Device: Health Professional
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.5 FRENCH NITINOL BASKET BY COOK MEDICAL; 4.5 FRENCH SEMI-RIGID URETEROSCOPE BY RICHARD WOLF; 6 FRENCH SEMI-RIGID URETEROSCOPE BY RICHARD WOLF; UNKNOWN ACCESS SHEATH; UNKNOWN HOLMIUM-YTTRIUM ALUMINUM GARNET LASER; UNKNOWN URETERAL STENT WITH STRING
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown