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

Model Number URF-V2

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated.Additional findings include; due to a pinhole on bending section cover and channel tube, water tightness was lost.Due to wear of angle wire, bending section could not be controlled at all.Distal end had discoloration.Control unit had corrosion due to water leakage.Light guide bundle was slipping down.The following had a scratch; video connector case, video connector, light guide connector, video cable, forceps elevator lever, angulation lever, insertion tube rotation ring, image guide protector, universal cord, up/down angulation lever plate, grip, switch box, scope cover, control unit, and connecting tube.The following was sticky; universal cord, up/down angulation lever plate, and grip.Adhesive on bending section cover had a chip.The connecting tube had a dent.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

It was observed that during the device evaluation that the angle locks due to wear of the angle wire on the videoscope.There were no reports of patient harm.

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.Based on the results of the investigation, a definitive root cause could not be established.Regarding the suggested phenomenon, the corrosion of the angulation mechanical portion was confirmed.Therefore, we presume that it caused to stick to a driving portion, stopping the motion of the mechanical portion.The instruction manual operation manual ¿chapter 3 preparation and inspection, 3.3 inspection of the endoscope¿ describes the methods for inspection on the suggested event.It is further recommended, for prevention of recurrence of the suggested phenomenon, it is suggested that the user facility review the method of device handling according to the instructions for use (ifu).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: 18710858
• MDR Text Key: 336526976
• Report Number: 9610595-2024-03235
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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: Other
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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