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

Model Number URF-V3R

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

Olympus customer care representative was informed by the customer via repair request, that the uretero-reno videoscope reportedly has a ¿bad image¿ found during inspection before use.The scope was returned, upon inspection and testing, the service evaluation identified up/down angulation could not be performed due to control movement is stuck.No death, injury or harm was reported.

Manufacturer Narrative

The service evaluation identified the up/down angulation could not be performed due to control movement is stuck.Additionally, the instrument channel is leaking, the bending section cover glue is lifting, there is restriction (unable to pass forceps/brush) in the instrument channel due to a deformation/dent in the insertion tube, the image is blurry, switch button (1) is not working, there is corrosion/rust inside the control body, and the light guide tube is buckled.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.If additional information becomes available a follow up medical device report will be supplemented accordingly.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to report source of the initial medwatch.The aware date should be (b)(6) 2022.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.The refurbished record was unable to be reviewed for this device.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 cause of the reported event is likely due to the a-wire became stuck in the a-coil pipe due to position slide of the a-coil pipe or corrosion of the a-wire and control section.The event can be detected/prevented by following the instructions for use which state: ifu (operation manual): ¿3.3 inspection of the endoscope_ inspection of the bending mechanism if the movement of the up/down angulation lock and the angulation control lever is loose and/or not smooth, or the bending section does not angulate smoothly, the bending mechanism may be abnormal.In this case, do not use the endoscope because it may be impossible to straighten the bending section during an examination, and patient injury, bleeding, and/or perforation may result inspection for smooth operation straighten the bending section.Confirm that the up/down angulation lock is placed in the free ¿f ¿ position.Operate the up/down angulation control lever slowly in each direction until it stops.Confirm that the bending section angulates smoothly and correctly and confirm that maximum angulation can be achieved.Operate the up/down angulation control lever slowly to its straight (neutral) position.Confirm that the bending section returns smoothly to an approximately straight position.¿ 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: 14018802
• MDR Text Key: 295240103
• Report Number: 8010047-2022-05766
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V3R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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