MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VA2

Device Problems Break (1069); Mechanical Jam (2983)

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

Event Date 02/08/2022

Event Type  malfunction  

Event Description

It was reported by the olympus representative on behalf of the customer, the visera cysto-nephro videoscope had an air leak.The issue was found at reprocessing after a procedure.There was no impact on the procedure.No patient harm reported.During the evaluation of the device, it was noted the angle locked due to the break in the angle wire.This report is to capture the reportable malfunction of the locked angle due to the break in the angle wire noted at estimation.

Manufacturer Narrative

The device was evaluated, and the reported issue was confirmed.Watertightness was not maintained due to breakage of the insertion tube due to external factors.Liquid leakage may be observed in the light guide bundle due to handling.There were scratches on the operation part, grip, universal cord, angle lever, video connector, and up/down angle fixing lever due to external factors.There was corrosion due to water leakage in the operation part.The bending section cover adhesive was missing.Switches one (1), two (2), and four (4) did not work.Liquid leakage may be observed in the grip due to handling.Liquid leakage was observed on the up/down plate.Paint floating was recognized on the up/down plate.Leakage was found on the universal cord.Wrinkles were found on the universal code due to external factors.Liquid leakage was observed on the light guide connector and light guide cover glass.The light guide connector and video connector may have been scratched due to external factors.Cloudy vision was observed due to internal humidity.The plating on the electrical contacts of the video connector may have been peeled off due to external factors.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.The device met all specifications at the time of shipment.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, the cause of the break in the angle wire likely occurred due to a cut in the insertion section serpentine and the internal wire was broken due to the moisture that entered the inside.This led to corrosion.The specific root cause of the break on the insertion section serpentine could not be determined at this time.The following information is stated in the instructions for use: "3.2 bore scope inspection 1.Visually check that there are no large scratches, deformation, or other abnormalities in the appearance of the operation parts or connectors.2.Confirm that there are no abnormalities such as bending, twisting, or bulging near the border between the oledome and the insertion." 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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13756605
• MDR Text Key: 296980262
• Report Number: 8010047-2022-04362
• 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: 04/15/2022

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: CYF-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2022
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 03/18/2022
• Supplement Dates FDA Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2013
• 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