MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problem Separation Problem (4043)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the uretero-reno videoscope was leaking and had insufficient tip curvature.There was no patient harm associated with the event.The device was returned and evaluated, and the flexible connecting tube of the image guide (resin part) was found to be falling off.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegations were confirmed.Water tightness was lost due to a cut on the connecting tube, a pinhole in the bending section cover, and a pinhole in the channel tube.Due to wear in the angle wire, the bending angles in both the up and down directions did not meet the standard value.In addition to the flexible connecting tube of the image guide (resin part) that was found to be falling off, the evaluation findings include the following: the adhesive on the bending section cover had a chip, the grip was sticky, the up/down plate was sticky, the universal cord was sticky, the control unit had a scratch, the grip had a scratch, the universal cord had a scratch, the control unit had corrosion due to water leakage, the light guide (lg) bundle was slipping down, the video connector case was dirty and had a scratch, the lg connector had a scratch, the lg cover glass had a scratch, the video cable had a scratch, the lock engagement lever had a scratch, the angulation lever had a scratch, and the video connector had a scratch.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to stress, handling, or other factors.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16086198
• MDR Text Key: 308111602
• Report Number: 3002808148-2023-00018
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1116-2022
• Patient Sequence Number: 1