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

Model Number CYF-VH

Device Problem Material Separation (1562)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

It was reported that the cysto-nephro videoscope's inner lining was coming off during reprocessing.There was no report of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the reported event was not confirmed.However, other evaluation findings are as follows: the leak test failed; the bending section cover had a cut; the bending section cover glue was chipped; the light guide lens were scratched; the bending section detached at the distal end; there was a tear inside the forceps passage channel; and there were scratches on the insertion tube.The foreign material found has been attributed to insufficient cleaning.The customer provided the cleaning, disinfecting, and sterilization process as follows: the device was cleaned, disinfected, and sterilized before it was sent in for repair.The customer has no idea about the nature of the foreign material.It is unknown if there was any delay in the start of the precleaning but there were no abnormalities in the accessories used for reprocessing.The customer flushed the air/water nozzle with water and air and wiped/brushed the air/water nozzle with clean lint-free cloths, brush, or sponges.The customer also flushed the air/water nozzle channel with the detergent solution.Attempts to retrieve additional information from the customer are in progress.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

Updated: h6, h10.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 in the channel could not be identified and a definitive root cause of the reported issue could not be determined, as there was no observed deformation that might result in the retention of foreign material and the facility device reprocessing was implemented in accordance to the ifu, however, it is possible that due to an observed leak, the foreign material could not be removed and or insufficient device cleaning /reprocessing.The event may be prevented by following the instructions for use sections below: cysto-nephro videoscope olympus cyf-vh olympus cyf-vhr reprocessing manual in addition, the following non-reportable malfunctions were found during the device evaluation: dunk test (leak test) failed, bending section cut, bending section chipped, light guide lens scratches, forceps passage tear inside channel, bending section distal end damaged/detached, insertion tube scratches.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17863270
• MDR Text Key: 324986755
• Report Number: 3002808148-2023-10682
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2023

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2020
• 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