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

Model Number CYF-VA2

Device Problem Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

A user facility reported that the visera cysto-nephro videoscope video reversed orientation of the connector assembly.During a standard service inspection of the customer returned device, rattling on the forceps cap mouthpiece was observed.This report is to capture the reportable malfunction found at inspection and there was no patient harm or user injury reported due to the event.

Manufacturer Narrative

The device was returned for investigation.Upon evaluation of the device, the reported issue was confirmed.In addition, a mouthpiece/t-tube mounting gap, looseness, deformation, scraping, rattling, detachment, and tilt damaged deformation due to physical stress were observed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this 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 (dhr) found no deviations that could have caused or contributed to the damaged forceps cap mouthpiece.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the issue occurred because the device was mishandled or subjected to stress forces.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: 15196041
• MDR Text Key: 305244706
• Report Number: 3002808148-2022-00808
• 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: 09/16/2022

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: 07/13/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 08/26/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2012
• 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