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

Model Number	CYF-VHA
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of adhesive peeling of the curved part was confirmed.There were no abnormalities with the appearance and operation of the subject device.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
An olympus employee reported on behalf of the customer, the adhesive on cysto-nephro videoscope was peeling at the tip bending part and the internal wire was exposed during maintenance.Similar issues occur frequently at the facility and recently cyf-va2 was repaired.The facility has 2x cyf-vha and 2x cyf-va, but the same problem is occurring with each.The devices are primarily cleaned and disinfected with endoscope reprocessor (oer-4).At the end of the day go through an ethylene oxide gas sterilization.There was no report of patient harm associated with this event.Event 1 of 4 this report is being submitted for the issue with the 1:2 cysto-nephro videoscope (cyf-vha), under the medwatch with patient identifier (b)(6).The issue with 2:2 cysto-nephro videoscope (cyf-vha) device is being reported on the medwatch with patient identifier (b)(6).The issue with 1:2 visera cystovideoscope (cyf-va) device is being reported on the medwatch with patient identifier (b)(6).The issue with 2:2 visera cystovideoscope (cyf-va) device is being reported on the medwatch with patient identifier (b)(6).
Additional 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, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to the bending section cover has a brush and the cross section is not flat, so we presume that the brush resulted in the lack of bending section cover.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Common Device Name: 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: 15936867
• Report Number: 3002808148-2022-05000
• Device Sequence Number: 20386055
• Product Code: FAJ
• UDI-Device Identifier: 04953170310508
• UDI-Public: 04953170310508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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
• Operator of Device: Health Professional
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OER-4.
• Patient Sex: Unknown