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

Model Number CYF-VA2

Device Problem Material Fragmentation (1261)

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

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated by olympus.In addition to the findings in describe event or problem, evaluation found water tightness was not maintained due to breakage of the insertion tube, the insertion tube was wrinkled, the forceps could not be inserted smoothly into the forceps channel, the channel brush could not be inserted smoothly into the forceps channel, the curved rubber adhesive was discolored, the insertion tube was broken, liquid leakage was found in the light guide connector and cover glass, the label on the light guide connector had come off, the universal cord was collapsed, plating of the video connector electrical contact was peeling, and scratches were found on multiple parts of the scope.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the control unit of the visera cysto-nephro videoscope had an air leak.The issue occurred during reprocessing.The name and type of the intended procedure was unknown.There was no delay and the procedure was completed.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found the forceps stopper cap scraped off.The report is being submitted due to scraped forceps cap found during evaluation.

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 root cause of the reported event is unable to be determined.However, the cause of the event is likely due to stress or user¿s handling.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: 15806370
• MDR Text Key: 307920752
• Report Number: 9610595-2022-04034
• 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: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• 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: 10/19/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2006
• 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