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

Model Number CYF-VA2

Device Problem Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.Upon inspection testing of the returned device, the user's request was confirmed.It was discovered, the water tightness was not maintained due to perforation of the forceps channel.In addition, there was liquid leakage was observed in the light guide bundle, in the operation part, in the grip part, and the up down plate.In addition, the curved rubber adhesive was missing, the insertion tube had wrinkles, the forceps plug cap was scraped off, the up/down plate paint was peeling, all the switches are not functioning due to damage to the switch box, switch button 1 is not functioning due to damage and the bending angle was insufficient due to the elongation of the angle wire.It was also noted, there were scratches on the operation part, the switch box, the grip, the insertion tube, the universal cord, the operation part side ore dome of the universal cord part, the angle lever, the video cable, the video connector, the video connector case, the light guide connector, and the up down angle fixing lever.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

An olympus representative reported to olympus, on behalf of the customer, the visera cysto-nephro videoscope channel had an air leak.Upon inspection and testing of the returned device, it was discovered forceps plug mouthpiece was scraped.There were no reports of patient harm associated with this event.The medical device report (mdr) is being submitted to capture the reportable malfunction of a scraped forceps plug mouthpiece found during evaluation.

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.It has been over 16 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to stress or user¿s handling.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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15485507
• MDR Text Key: 306319579
• Report Number: 3002808148-2022-02436
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

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: 08/28/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2006
• 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