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

Model Number CYF-V2

Device Problem Break (1069)

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the bending rubber of the visera cysto-nephro videoscope was broken and the metal was sticking out.The scope cap was not on during the the sterilization period.The issue was found during reprocessing.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation, however, no information has been provided at the moment.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.Based on the results of the investigation, a definitive root cause of the reported ¿bending rubber is broken/torn/ruptured and the metal is sticking out¿ and ¿device washed with sterilization cap on¿ issues could not be determined, as the device has not been returned to olympus for evaluation, however, the reported issues were likely the result of user mishandling.The event can be prevented by following the instructions for use which state: olympus ltd type v2 - chapter 6 compatible reprocessing methods and chemical agents 6.6 ethylene oxide gas sterilization caution attach the sterilization cap to the endoscope before ethylene oxide gas sterilization.If the sterilization cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism (see figure 6.2).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: 17917117
• MDR Text Key: 326260694
• Report Number: 3002808148-2023-11153
• 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: 12/01/2023

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-V2
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 11/24/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2009
• 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