MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VA2

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

Olympus (omsc) was informed that the customer visera cysto-nephro videoscope was returned to the olympus repair center for a reported ¿pinhole¿.The problem was found during an unspecified event.Upon inspecting and testing, the forceps plug was found to be loosening.No death, injury or harm was reported.This report is being submitted to capture the forceps plug was found to be loosening.

Manufacturer Narrative

The service evaluation confirmed the customer¿s reported issue as the scope failed the leak due to scratches/cuts on the insertion tube.The insertion tube is collapsed/dented causing restriction in the instrument channel.The insertion tube is kinked below the protector boot cover.The bending angulation is below standard due to a stretched angle wire.The bending section cover adhesive is peeling off.The forceps stopper is loose.The electrical contacts of the video connector are damaged, wrinkles on the universal cord.The video cable is difficult to remove from insufficient cleaning.There are scratches on the following: the video connector, the control body, on the switch box unit, the grip, the angle lever, the up/down plate, the universal cord, on the video cable, the light guide connector, the video connector case and the up/down angulation lever.The investigation is ongoing.Therefore; the root cause of the reported issue cannot be determined at this time.However; if additional information becomes available this medical device report will be supplemented accordingly.

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 most likely occurred due to stress, handling, or other factors.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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14727425
• MDR Text Key: 300471203
• Report Number: 8010047-2022-10224
• 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: 08/10/2022

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: 05/22/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2008
• 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