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

Model Number URF-V2

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

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This report has been reported by the importer on mdr# 2951238 - 2021 - 00414.

Event Description

It is reported in the literature abstract titled ¿single-use versus reusable endoscopes for percutaneous biliary endoscopy with lithotripsy: technical metrics, clinical outcomes, and cost comparison¿, one patient in the reusable scope group experienced a gall bladder perforation during a percutaneous biliary endoscopy (pbe) procedure using an olympus urf-2 ureteroscope, requiring a biliary tube placement.There is no report of olympus device malfunction in this literature abstract.Study purpose: percutaneous biliary endoscopy (pbe) is increasingly used by interventional radiology (ir) to visualize and treat biliary pathology.Advances in endoscope technology have introduced single-use, disposable endoscopes to complement traditional, reusable endoscopes; however, data comparing the two technologies is limited.In this study, we compare the technical metrics, clinical outcomes, and costs between single-use and reusable endoscopes for use in pbe.Method: this was a retrospective study.Sixty-seven pbe procedures were performed on 34 patients (62% male; mean age 65.9 [range 5-90] years) for stone removal from october 2014 to february 2020, using either reusable (n- 17 patients, 28 cases; olympus urf-2 ureteroscope) or single-use endoscope (n-17 patients, 39 cases; boston scientific lithovue ureteroscope).Device metrics, technical and clinical success, complications, and cost-per-case were compared.Results: single-use endoscopy performed as well or better in several performance metrics compared to reusable endoscopy, including flexion, tip deflection, irrigation flow, and ease-of-use.Mean procedural time was similar between single-use (mean ± sd; 136.4 ± 44.6 minutes) and reusable (135.5 ± 51.2 minutes; p = 0.5) endoscopes, while mean fluoroscopy time was significantly lower with single-use endoscopes (11.7 ± 8.4 minutes) compared to reusable (17.6 ± 11.8 minutes; p = 0.01).Technical and clinical success with single-use endoscopes was 95% (n -37) and 90% (n -35), respectively, similar to reusable endoscope use at 93% (n -26) and 75% (n -21), respectively (all p > 0.05).One complication in the perioperative period occurred during reusable scope use, involving gallbladder wall perforation, whereby the biliary tube was replaced without further complications.Conclusions: this study supports disposable endoscopes as a safe and effective alternative to reusable endoscopes for patients undergoing pbe.Additionally, disposable endoscopes demonstrated significantly decreased fluoroscopy time compared to reusable endoscopes, offering the potential for lower patient radiation exposure, as well as a lower cost-per-case, which may lower financial barriers to starting or expanding pbe in an ir practice.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h6 and h10.The device history record (dhr) for the complaint device could not be reviewed since the lot number was not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: the definitive cause could not be established.Since there is no report of a device malfunction, the likely cause is another factor such as procedural complication, or patient condition/anatomy challenges.

Manufacturer Narrative

This supplemental report includes a correction to g2 and h6.Information added to these fields that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• 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: 12516818
• MDR Text Key: 272878184
• Report Number: 8010047-2021-12157
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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
• Date Manufacturer Received: 02/08/2023
• 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; Other