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

Model Number CYF-VA2

Device Problem Degraded (1153)

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

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by olympus.The evaluation found that the allegation was confirmed.Additional issues were identified during the device evaluation: a cut in the connecting tube causing watertightness to be lost; a pinhole in the channel-tube causing watertightness to be lost; the forceps channel port was shaved; the distal sheath had slack; the connecting tube had a dent with a wrinkle; the light guide protector had a cut; the indicator on the grip is unclear and had a scratch; the universal cord had a dent and was scratched; due to wear on the angle wire, bending the angle in the up direction did not meet the standard value; due to damage on the channel tube, forceps could not be inserted smoothly; and due to damage on the channel tube, the channel cleaning brush could not be inserted smoothly.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The olympus representative reported that the visera cysto-nephro videoscope was found to have air and water leakages.No patient injury or procedure impact was reported.During the evaluation of the device, it was noted that the t-tube fitting had defects due to physical stress on the device.This report will document the reportable malfunctions and defects on the t-tube that were discovered during the estimation process.

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, it was not possible to determine whether the scraping of the forceps base was 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): 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: 16315747
• MDR Text Key: 309560450
• Report Number: 9610595-2023-01949
• 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: 03/08/2023

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: 01/10/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2008
• 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