MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VA2

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

The customer reported that the cysto nephrovideoscope's remote switches were nonfunctional and there was a generation of noise including vertical line, horizontal line and a spotted noise.There were no reports of patient harm.During the device evaluation, the following reportable malfunction was found: light guide lens and objective lens had foreign objects.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation, and the evaluation found that due to damage on the charged coupled device unit, a noise image occurred; due to damage, switches 3 and 4 did not work; the light guide lens and objective lens had foreign objects; due to a pinhole on the channel tube and connecting tube, water tightness was lost; the light guide bundle was slipping down; and because the channel tube was crushed, forceps could not be inserted.Due to the wear of the angle wire, the bending angle in the up direction did not meet the standard value; the control unit was sticky due to water leakage; the angulation lever, forceps elevator, lock engagement lever, switches 1,2,3,4 and switch box, and protector of the universal cord on the suction connector side had discoloration.Due to damage to the charged coupled device unit, a foggy image occurred; the universal cord had a dent, and the universal cord, up and down angulation lever plate, and grip were sticky.The bending section cover or distal sheath had a scratch.Due to a data error of scope id, an e216 scope communication error occurred.The protector of the video cable section had a stain, the label on the light guide connector was peeled, and the control unit was sticky due to water leakage.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

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, the observed foreign material at the objective lens and illumination lens of the device could not be identified and a definitive root cause of the issue could not be determined, however, the facility device reprocessing was not implemented in accordance with the ifu and the issue was likely the result of insufficient device cleaning/reprocessing.The issue may be prevented by following the instructions for use below: ·chapter 6 application and conditions of cleaning, disinfection, and sterilization.·chapter 7 cleaning, disinfection, and sterilization procedures.Reprocessing survey info: - the device was cleaned, disinfected, and sterilized before being sent to olympus.- no delay in the start of pre-cleaning.- no abnormalities in the accessories used for reprocessing.- did not soak the endoscope in cleaning solution.- the air/water nozzle was not wiped/brushed with clean lint free cloths, brushes, or sponges.Olympus will continue to monitor field performance for this device.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO 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: 18411024
• MDR Text Key: 331865971
• Report Number: 9610595-2023-20503
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339455
• UDI-Public: 04953170339455
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133538
• 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: 01/31/2024

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: Health Professional
• Device Model Number: CYF-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2007
• 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