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

Model Number URF-V

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

As part of the investigation into a report of no image, a physical evaluation of the device was conducted by an olympus repair technician at an olympus repair facility.During this evaluation, it was discovered that there was a scrape on the forceps mouthpiece, in the instrument channel port.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

Upon an inspection of the uretero-reno videoscope by an olympus technician at an olympus repair facility following reports of no image, it was discovered that there was a scrape on the forceps mouthpiece, in the instrument channel port.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the device evaluation.

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 12 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the scraped instrument channel port was caused by load, handling, or other issues.The root cause of this event was unable to be identified.Additionally, during the device evaluation, the repair center found: no image due to damaged charged coupled device.Watertightness of the distal end cover is lost.Scratches on the bending rubber glue.Dent on the insertion tube.Bending angle is insufficient due to stretched angle wire.Insertion failure of the accessories occurred in the forceps channel.Scratches on the control section.Indicators on the control section are peeled.Scratches and wrinkles on the universal cord.Burn mark on the distal end cover.Scratches on the light guide connector and video connector case.Video connector case has dirt that is hard to remove.However, these defects are not considered severe enough to cause a potential adverse event.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: 16075229
• MDR Text Key: 308471710
• Report Number: 3002808148-2022-05748
• Device Sequence Number: 1
• Product Code: FGB
• 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: 01/30/2023

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: 11/29/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2010
• 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