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

Model Number URF-V2

Device Problem Use of Device Problem (1670)

Patient Problem Internal Organ Perforation (1987)

Event Type  Injury  

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.

• 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
• MDR Report Key: 12516813
• MDR Text Key: 272852960
• Report Number: 2951238-2021-00414
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343582
• UDI-Public: 04953170343582
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2021,09/22/2021

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?: Yes
• Distributor Facility Aware Date: 08/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention