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

Model Number CYF-VA2

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Event Description

Olympus (omsc) was informed that the olympus loaner visera cysto-nephro videoscope was returned to the olympus repair center for a reported ¿roughness when installing the contents of the vent metal plate¿.The customer reported issue was found during an unspecified event.However, during the repair inspection the forceps plug mouthpiece was found scraped off.No death, injury or harm has been reported to olympus.This report is being submitted to capture the scraped off forceps plug mouthpiece.

Manufacturer Narrative

The repair inspection confirmed the customer¿s reported issue, the vent metal on the light guide connector is deformed.Additionally, the forceps plug cap has been scraped off.The inspection also noted the flexible insertion tube is deformed/crushed and wrinkled.There is an abnormal noise when manipulating the angulation lever.A part of the adhesive on the bending section cover is missing.Corrosion on the light guide connector and inside the light guide coverglass.The labeling on the light guide connector has come off.The image abnormalities (flare/ghost).The paint is peeling on the up/down lever plate.The universal code is collapsed.The electrical contacts of the video connector are scraped.There are scratches on the following parts of the scope: insertion tube, control body, switch box, light guide connector, protective cover boot of the insertion tube, grip, up/down lever plate, universal code, video cable, video connector and video connector case.The investigation is ongoing; therefore, the cause of the customer event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.

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 stress, handling, or other issues.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3002808148.

• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15925833
• MDR Text Key: 308352582
• Report Number: 9610595-2022-04971
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2024

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: Other
• Device Model Number: CYF-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 12/09/2022; 05/09/2024
• Supplement Dates FDA Received: 01/06/2023; 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2005
• 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