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  

Manufacturer Narrative

In addition to the phenomena identified in b5, the following phenomena were also identified during evaluation that due to corrosion, sw1 does not work, due to a pinhole on channel tube water tightness was lost, adhesive on bending section rubber had a chip, connecting tube had a dent, up/down angulation plate was sticky, universal cord was sticky, indication on light guide connector was not correct, control unit was sticky due to water leakage, due to wear of angle wire bending angle in up direction did not meet the standard value, due to a dent on channel tube forceps cannot be inserted smoothly, light guide bundle is slipping down, and due to damage on charged coupled device unit foggy image occurs.Due to the nature of the reportable event (foreign material found in the nozzle), follow up regarding the cleaning sterilization and disinfection (cds) processes performed at the user facility was requested.Customer provided the following information: device was cleaned, sanitized and disinfected prior to sending the device for repair.Facility was not aware what the foreign material was.Brushed points for air/water channel performed with clean lint ¿free cloths, brushes, sponges- facility noted that there was no abnormalities on the accessories used for reprocessing facility noted that the customer did not aspirate the water through the instrument/suction channel nor did they presoak the endoscope in the detergent solution.Facility did not note any comments or concerns regarding reprocessing.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the flex video scope was making the switch sound after a delay following the press.The issue was found during an unknown event.The device was returned for evaluation.During the device evaluation, the foreign material at the tip of the brush was found.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation and the information provided, it could not be determined what the foreign material was.There was no damage to the area where the foreign material was detected.The foreign material may have remained in the nozzle since the reprocessing performed was deviated from the instruction manual.However, specific root cause could not be determined.The event can be detected/prevented by following the instructions for use: cyf-va2 instruction manual, chapter 6 compatible reprocessing methods and chemical agents and chapter 7 cleaning, disinfection, and sterilization procedures.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: 18412336
• MDR Text Key: 331624168
• Report Number: 9610595-2023-20519
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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: 01/29/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2008
• 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