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

Model Number CYF-VHA

Device Problem Material Puncture/Hole (1504)

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

Event Date 05/20/2023

Event Type  malfunction  

Event Description

The customer reported to olympus during postoperative observation after an unspecified diagnostic procedure, it was observed that there was a hole in the insertion part of the cysto-nephro videoscope and the metal inside was visible.The procedure had been completed using the same device, the patient was under mucous anesthesia only, and no delay was noted.There were no reports of patient harm or impact associated with this event.

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Root cause of the event could not be identified.Presumable root causes: (1) since the sterilization cap was used and there was no breakage in bending section cover (a-rubber), it could be seen that it was not caused by the misuse of the sterilization cap at the time of sterilization.(2) since there was a dent around the rupture of the insertion part snake tube, it is presumed that the insertion part snake tube was damaged when some stress was applied, leading to the rupture.Based on the results of the investigation, it was confirmed that there was a rupture in the insertion part snake tube and that the metal inside was exposed; it was confirmed that there was no protrusion in the above internal metal; it was confirmed that there was a dent around the rupture of the insertion part snake tube; it was confirmed that there was no occurrence of the breakage in bending section cover (a-rubber); it was confirmed that the sterilization cap was used.Additionally, investigation results revealed the following: wrinkled tubing at insertion site; scratches are found on the operation unit tube, grip, and scope- cover; universal code, with scratches on video cable; video connector case, light guide connector was scratched; there was a shortage in angle; and imaging abnormalities (image inversion) had occurred.Olympus will continue to monitor field performance for this device.

• Brand Name: 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 (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17168083
• MDR Text Key: 318270898
• Report Number: 3002808148-2023-06204
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411274
• UDI-Public: 04953170411274
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/20/2023

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-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• 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
• Treatment: CLV-S190 (SERIAL NO.(B)(6)); OTV-S190 (SERIAL NO.(B)(6))
• Patient Age: 56 YR
• Patient Sex: Male