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

Model Number URF-V3

Device Problems Naturally Worn (2988); Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Event Description

The olympus representative reported the forceps channel on the uretero-reno videoscope had a pinhole (leakage).No patient injury reported.During the evaluation of the device, it was noted the angle locked due to wear of the angle wire.This report is to capture the reportable malfunction of the locked angle due to wear of the angle wire noted at estimation.

Manufacturer Narrative

Additional information was requested from the reporter.No additional information was available.The device was returned to olympus for evaluation and the reported issue was confirmed.Water tightness was not maintained due to perforation of the forceps channel due to external factors.Water tightness was not maintained due to tip cover chipping due to external factors (tip collision).Due to handling (insufficient cleaning), the tip cover had dirt that was difficult to remove.The forceps could not be inserted smoothly due to buckling of the forceps channel due to external factors.Liquid leakage was recognized in the light guide bundle due to handling.Corrosion due to water leakage was found in the operation part.The bending section cover adhesive was missing.Switch four (4) had a bad contact.Liquid leakage was observed in the grip part due to handling.Liquid leakage was observed in up/down plate and universal cord.Scratches were found in multiple locations on the device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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.The suggested phenomenon was presumed to have been due to either a strong twisting operation of the bending section to the right and left in the condition of angulation locked, or by the irregular load such as immediate angulation.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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15292235
• MDR Text Key: 305265458
• Report Number: 9610595-2022-01288
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181451
• 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: 10/14/2022

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-V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2018
• 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