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

Model Number CYF-240A

Device Problem Degraded (1153)

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

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by olympus.The evaluation found that the allegation was not confirmed.Additional issues were identified during the device evaluation: the connecting tube was dented and deformed; the angulation in the "up" direction was out of standard due to worn angle wire; the gripped part was deformed; and there was a 3rd party repair performed on the device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus representative reported that during preparation for use in a diagnostic procedure, the evis cysto videoscope developed an air/water leakage from the insertion bending section.The intended procedure was completed with a similar device.There were no reports of patient harm associated with this event.During the evaluation of the device, it was noted that the channel mount was worn.This report is to capture the reportable malfunction of the worn channel mount noted at estimation.

Manufacturer Narrative

Device manufacture date- apr 13, 2015 should have been selected on the initial report rather than apr 4, 2015.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 root cause of the event was unable to be identified; however, it is likely that the event occurred due to the metal part of the treatment tool or cleaning brush interfered with the forceps plug mouthpiece when inserting or removing the treatment tool or cleaning brush.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS CYSTO 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: 16065011
• MDR Text Key: 308392658
• Report Number: 9610595-2022-06233
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 02/15/2023

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: CYF-240A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 01/24/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• 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