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

Model Number CYF-VA2

Device Problems Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

Customer reported with an issue of a-rubber (bending manipulation/insertion tube) adhesive part chipped.The issue found during an unknown event.There was no patient harm, no user injury reported due to the event.Device evaluation found the forceps stopper is scraped (forceps mouth scrapping).This report is being submitted for forceps stopper is scraped, found during device evaluation.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation and inspection, service repair noted the following findings: device inspection noted curved rubber adhesive is missing/peeling.Poor insulation performance at the tip is observed due to adhesive peeling of the curved rubber.The customer reported issue could be confirmed.Furthermore, the following findings during inspection were noted on the device: the forceps plug cap has been scraped off due to external factors.The flexible tube of the insertion section found crushed due to external factors.The display of the insertion tube noted unclear.Scratches on the insertion tube due to external factors observed.Wrinkles in the insertion tube due to external factors observed.Insufficient bend angle due to angle wire elongation the operating part noted deformed due to external factors.Scratches found on the operation part due to external factors.Scratches are found on the switch box due to external factors.The universal cord found deformed due to external factors.Scratches are found on the universal cord due to external factors.Scratches are found on the grip due to external factors.There are scratches on the angle lever due to external factors.Peeling of the paint is recognized on the (up/down) ud plate.Scratches are found on the ud plate due to external factors.Up/down plate replacement operation part ud plate broken parts, damage, deformation noted.Scratches are found on the video cable due to external factors.Wrinkles are observed in the video cable due to external factors.Scratches are found on the video connector due to external factors.The electrical contact of the video connector has been scraped due to external factors.Scratches are found on the lg connector due to external factors.Scratches are found on the video connector case due to external factors.There are scratches on the ud angle fixing lever (sp) due to external factors.The label on the lg connector has come off.Investigation is ongoing.This report will be supplemented accordingly following 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.It has been over 15 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely due to stress, handling, or other issues.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: 15198221
• MDR Text Key: 304902375
• Report Number: 3002808148-2022-00762
• 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
• Report Date: 09/14/2022

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: Other
• Device Model Number: CYF-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1