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

Model Number CYF-VA2

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Event Description

The customer reported to olympus that the visera cysto-nephro videoscope had insertion tube damage.There were no reports of patient or user harm associated with this event.The device was returned to olympus for a device evaluation and found the forceps channel port was shaved.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for a device evaluation and the customer's allegation was confirmed.In addition to the reported in b5, the device evaluation found the following: the connecting tube had a cut, due to a cut on the connecting tube the water tightness was lost, part of the connecting tube was fallen off, due to damage on the channel tube the forceps could not be inserted smoothly, due to damage on the channel tube the channel cleaning brush could not inserted smoothly, due to a scratch on the objective lens the image had a partially dark area, the video connector case had a scratch, the video connector had a scratch, the light guide connector had a scratch, the protector of the video cable section had a scratch, the video cable had a scratch, the lock engagement lever had a scratch, the angulation lever had a scratch, the grip had a scratch, the switch box had a scratch, the suction cover had a scratch, and the control unit had a scratch.Based on the results of the investigation, the root cause could not be determined.The device history record was unable to be reviewed as the subject device was manufactured over 15 years ago.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.A labeling review was not applicable because we could not determine if the phenomenon occurred due to the handling methods of users.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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18084110
• MDR Text Key: 327523832
• Report Number: 9610595-2023-16608
• 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
• Report Date: 11/07/2023

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: 10/16/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2007
• 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