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

Model Number URF-V

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

Patient Problem Perforation (2001)

Event Type  Injury  

Event Description

Olympus reviewed the following literature article: "determining whether previous swl for ureteric stones influences the results of ureteroscopy as the second-line treatment: a clinical study" by catalin pricop, marius ivanuta, and george daniel radavoi, et al.This study was aimed to determine whether shock wave lithotripsy (swl) is a limiting and potentially harmful first-line procedure for ureteric stones where ureteroscopy (urs) is necessary as a second-line treatment to render a stone-free status.A total of 158 patients were included in two groups (n=79 each): group a comprised patients with no swl before urs, and group b comprised patients who previously had swl.The results discussed for the urs with pneumatic lithotripsy, as a first therapeutic method, while comparing it with those of the urs after a failed swl for ureteric stones.Group a had higher stone-free rates; group b had higher rates of ureteral edema and similar intraoperative ureteral lesions.The study concluded that the failure of swl for lumbar or pelvic ureteral lithiasis does not appear to have a negative effect on the rate of intraoperative complications or the success rate of semi-rigid retrograde urs for this category of calculi, with the same safety profile as first-line endourological intervention.  the authors used  one olympus device and reported the following adverse events: 5 minor perforations in group b (olympus ureteroscope).

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The legal manufacturer has completed the investigation.The device history records review can not be performed since no serial number was provided.Olympus ships devices that are manufactured according to all specifications and meet final release criteria.The legal manufacturer was unable to determine the root cause of the reported event and no device malfunctioned.It is unknown what the causal relationship is between the device and the adverse event.

• 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: 13543118
• MDR Text Key: 285694318
• Report Number: 8010047-2022-03039
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2022

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-V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/16/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other