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

Model Number CYF-VA2

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found due to a pinhole on the distal end, water tightness was lost.Due to wear of angle wire, bending section cannot be controlled at all.Adhesive on the distal end was detached.Light guide-bundle was slipping down.Due to damage on the channel-tube, channel cleaning brush cannot be inserted smoothly.Due to damage on channel-tube, forceps cannot be inserted smoothly.Control unit has corrosion due to water leakage.Label on video connector was peeled.Electrical contact of video connector was shaved.Label on light guide connector is peeled.Due to damage, switch 1 does not work.The switch box had discoloration.The video connector case was sticky.The video connector had discoloration.The light guide connector had corrosion.The light guide-cover glass had corrosion.The video cable was sticky.The universal cord was sticky.The up down plate was sticky.The grip was sticky.The connecting tube had a wrinkle.Due to damage, the switch 4 does not work.In addition the video connector case, the video connector, the light guide connector, the video cable, the universal cord, the control unit, the connecting tube, the grip, the locking engagement lever, the angulation lever, and the forceps channel port were all scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, there was air/water leakage from the distal end of the visera cysto-nephro videoscope.Inspection and testing of the returned device found angle locked due to angle wire wear.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction 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.Based on the results of the investigation, the root cause of the event was unable to be identified; however, the event likely occurred due to mishandling.The event can be detected/prevented by following the instructions for use which state: "do not damage the endoscope¿s distal end, insertion tube, bending section, video connector, and light-guide connector when you transport and reprocess the endoscope." 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: 16909037
• MDR Text Key: 314976003
• Report Number: 3002808148-2023-04738
• 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: 06/01/2023

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-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2005
• 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