MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VIDEOSCOPE "CYF-VA2", WITH SUCTION, EUROPEAN VERSION; CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VA2

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the tip fell off the videoscope "cyf-va2", with suction, european version.This occurred after a procedure.There was no delay to therapy or report of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.However, during device evaluation, the following findings were noted : an abnormal appearance and air/water leakage from the connector; deformation, buckling, dents, scratches, cuts, and wrinkles on the insertion parts; chipping of the tip/curved rubber adhesive; an appearance abnormality of operation parts (including the switch); and a crushed video cable.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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.Olympus will continue to monitor field performance for this device.

• Brand Name: VIDEOSCOPE "CYF-VA2", WITH SUCTION, EUROPEAN VERSION
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17303065
• MDR Text Key: 319026093
• Report Number: 9610595-2023-09975
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339455
• UDI-Public: 04953170339455
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

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: 06/16/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2011
• 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