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 Problems Pneumonia (2011); Urinary Tract Infection (2120); Hematuria (2558); Unspecified Kidney or Urinary Problem (4503); Insufficient Information (4580)

Event Type  Injury  

Event Description

Olympus reviewed the following literature article: "significance of presenting for ureteral stones that were tuled at osaka labor disaster hospital." abstract: [purpose] the significance of prestenting for ureteral stones subjected to tul was examined.[subjects and methods] 192 cases were enrolled from 2012 to 2019.Stone free (sf) is defined as 4 mm or less.[results] the subject patients were 19 to 88 years old.Prestenting was performed in 72 cases, and 154 cases (802%) became sf.In multivariate analysis, performances status (ps) was poor (p = 0.013), ct values were high (p = 0.0015), and the frequency of prestenting was significantly higher except for ca stones (p = 0.0215).However, there was no significant difference in sf.[discussion / conclusion] as mentioned above, the background factors are quite different, so it was felt that further study was needed on the significance of prestenting.The authors reported the following adverse events: 1.(clavien-dindo classification g3 or higher) were found in 25 cases 2.Urinary tract infections in 19 cases 3.And hydronephrosis in 3 cases 4.Hematuria 1 case 5.Hematuria & bladder tamponade & urinary tract infection 1 case 6.Aspiration pneumonia 1 case.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

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 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 event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.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: 14374123
• MDR Text Key: 291504899
• Report Number: 8010047-2022-08124
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340321
• UDI-Public: 04953170340321
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 08/30/2022

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: 03/09/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 08/03/2022
• Supplement Dates FDA Received: 08/30/2022
• 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
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other