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

Model Number CYF-240A

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation the connecting tube is wrinkled, and the forceps channel port was not secured.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the videoscope forceps part was turning.The issue occurred during an unknown diagnostic procedure.The procedure was completed with a similar device.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The customer's complaint was confirmed.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 is likely that the event occurred due to one or more of the following: the biopsy channel port rotated from the assembled position.The k-mount (insertion section mount) unit was deformed at the area where the port was assembled.The area receives rotation torque on the port.It is likely the above occurred more specifically due to one or more of the following: 1.The user tightened the locking ring of maj-891 forceps/irrigation plug with excessive force when attaching the plug to the port.2.The port, that the plug is attached, received torque generated by the above.3.The above caused deformation of the k-mount (the port assembled area).The area receives rotation toque on the port.4.The port became easy to rotate due to the above deformation.5.Due to repeated attachment of the plug, the port rotated more and more.However, the definitive root cause was unable to be determined.The event can be prevented by following the instructions for use (ifu): instructions olympus cyf type 240a chapter 3 preparation and inspection_ 3.3 inspection of the endoscope_ inspection of the endoscope.Olympus will continue to monitor field performance for this device.

Event Description

The procedure had a delay (unknown how long) and the patient was under anesthesia at the time the malfunction occurred.

• Brand Name: EVIS CYSTO 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: 18712536
• MDR Text Key: 336526036
• Report Number: 9610595-2024-03269
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-240A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2015
• 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