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

Model Number URF-V2R

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Unspecified Kidney or Urinary Problem (4503)

Event Date 04/19/2022

Event Type  Injury  

Event Description

Olympus was informed of the following event by the fda via mw5109368.The customer reported while the surgeon was using olympus flex ureteroscope v2r, he was unable to straighten and use the scope.It was also reported that the scope kinked in the ureter and surgeon had to use multiple wires to set the scope free/straighten.The intended therapeutic cystoscopy, left retrograde pyelogram, left ureteroscopy, laser lithotripsy, stone extraction of both ureteral and renal calculi, ureteral stent exchange was cancelled due to this issue.Patient required a stent and may require additional surgery at a later date.In addition, the customer reported the subject device was inspected prior to the procedure and no issues were found.The customer does not know when the device failure occurred during the procedure and if there was a procedural delay.

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.This report has been submitted by the importer under this mdr report number (b)(4).

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.New information added to the following fields: h4, h6, h10.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer could not determine the probably cause since the device was not returned and additional information was not received from the customer.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: 14523421
• MDR Text Key: 293694143
• Report Number: 8010047-2022-09045
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170343612
• UDI-Public: 04953170343612
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2017
• 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; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 48 KG