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

Model Number CYF-V2

Device Problem Device Reprocessing Problem (1091)

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the visera cysto-nephro videoscope had problems related to reprocessing and was sterilized without an ethylene oxide cap.The issue was found during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found a ruptured bending section cover, a leak at the ruptured bending section cover, cracked glue, no image, a peeled video cable and light guide tube, and a cracked video connector.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the legal manufacturer's final investigation.Updated fields: h4, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for evaluation and the customer's allegation was confirmed.Based on the results of the investigation, the event likely occurred during to mishandling of the device during reprocessing.The event can be detected and prevented by handling the device in accordance if the instructions for use which state: chapter 7 cleaning, disinfection, and sterilization procedures: caution ¿ attach the eto cap to the venting connector before sterilizing.If the eto cap is not attached to the endoscope during sterilization, the vacuum created within the sterilization chamber can rupture the covering of the bending section.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): 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: 18440287
• MDR Text Key: 331879491
• Report Number: 3002808148-2024-00093
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411199
• UDI-Public: 04953170411199
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• 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