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

Model Number URF-V3

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

A device evaluation confirmed the customer allegation.Air/water leakage was noted at distal end.Defects were found in the biopsy channel.Fluid invasion from the control body unit was noted.The control knob movement was defective.The investigation is ongoing.A supplemental will be submitted in completion of investigation or if any additional information is available.

Event Description

The customer reported to olympus, the uretero-reno videoscope exhibited leakage at the distal end when a leak test was performed during reprocessing.The device was returned and an evaluation revealed, the angulation lever was frozen.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no patient involvement.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15888429
• MDR Text Key: 307684300
• Report Number: 9610595-2022-04696
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170403385
• UDI-Public: 04953170403385
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2022

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: 11/10/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2021
• 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