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

Model Number CYF-VA2

Device Problem Scratched Material (3020)

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

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.Upon inspection testing of the returned device, the user's request was confirmed.It was discovered, the water tightness was not maintained due to breakage of the insertion tube.In addition, the flexible tube of the insertion section was crushed, the insertion tube was wrinkled, the bending angle is insufficient due to the elongation of the angle wire, the forceps cannot be inserted smoothly due to the forceps channel being crushed, the channel cleaning brush cannot be inserted smoothly, the universal code was collapsed and the forceps plug cap was been scraped off.It was also noted, there were scratches on the angle lever, the operation part, the insertion part corrugated tube ore dome, the switch box, the grip, the up down plate, the universal cord, the video cable, the video connector, the light guide connector, the video connector case, and the up down angle fixing lever.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus, the visera cysto-nephro videoscope had a water leak.Upon inspection and testing of the returned device, it was discovered the forceps plug cap was scraped.There were no reports of patient harm associated with this event.The medical device report (mdr) is being submitted to capture the reportable malfunction of a scraped forceps plug mouthpiece found during evaluation.

Event Description

According to the reporter, the event occurred on august 23, 2022, during reprocessing.The intended procedure was a diagnostic bladder observation.There was no delay in the procedure.The procedure was completed using the same set of equipment.A pre-use inspection was performed and there was no abnormality.There are no additional details regarding the patient or event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event and 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 reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, the root cause of this phenomenon could not be identified.Olympus was unable to determine that the cause of the instrument channel outlet scraping was attributed to stress or user¿s handling.Olympus will continue to monitor the field performance of 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: 15487147
• MDR Text Key: 306176120
• Report Number: 3002808148-2022-02448
• 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: 10/13/2022

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: 08/28/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/28/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2018
• 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