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

Model Number URF-P6

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

The event date was reported as the publication date of the literature.The documented olympus device used in the literature was flexible ureterorenoscope (flex x2, storz or p6).Olympus used urf-p6, as representative product for this report.The literature 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.

Event Description

Olympus medical systems corp.(omsc) received a literature titled, "an observational study to evaluate the feasibility, stone-free rate, and complications of rirs in children <5 years of age." a retrospective study evaluated the feasibility, stone-free rate, and complications of retrograde intrarenal surgery (rirs) in children <5 years of age.A total of 50 pediatric patients were included in the study, of which 4 had bilateral renal stones and 4 patients had multiple stones in the same renal unit.The stones were mostly located in the pelvis and the lower pole.The mean operative time and hospital stay were 55.2±11.4 (36.4-80.5) and 62.1±11.1 (40.4-83.2).Thus, the study concluded that pediatric rirs is a promising option for young children as it offers acceptable stone-free rates and a low incidence of high-grade complications.Type of adverse events/number of patients: event1: ureteric damage - grade 1 (traxer and thomas classification) - 1 patient, event2: ureteric damage - grade 2 (traxer and thomas classification) - 1 patient, event3: postoperative complications - g1, g2, g3a, g3b (clavien¿dindo classification) - 19 patients.Two ureteric injuries grade 1 and grade 2 according to classification described by traxer and thomas were managed with prolonged double j stenting for 4 weeks.At follow-up for a mean period of 32 months, these two cases did not reveal any ureteric stricture, which we attribute to the prior stenting.There is no olympus device malfunction documented in the article.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 is no evidence of an olympus device malfunction.In addition, the malfunction of the device has not been reported, and from clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: 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: 17909378
• MDR Text Key: 325339316
• Report Number: 9610595-2023-14927
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340802
• UDI-Public: 04953170340802
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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: Not provided
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/06/2023
• 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): Required Intervention