MAUDE Adverse Event Report: AIZU 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 a bad 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.Additional evaluation findings are as follows: 1.)due to damage on charge-coupled device unit, the image noted to have linear scratches; 2.) poor image quality noted; 3.) due to wear of angle wire, bending angle in up direction did not meet specification; 4.) scratches were found on the curved rubber adhesive part; 5.) liquid leakage was noted in the light guide connector due to handling; 6.) light guide connector noted scratched; 7.) liquid leakage is noted inside the light guide cover glass; 8.)scratch noted on control unit, grip, universal cord, video cable, video connector and video connector case.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 a bad 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 14 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.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16075058
• MDR Text Key: 308538584
• Report Number: 9610595-2022-06297
• 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: 08/19/2008
• 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