MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-VHA

Device Problems Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

Customer reported with an issue of air leakage.The issue found during an unknown event.There was no patient harm, no user injury reported due to the event.Device evaluation found the forcep stopper is scrapped.

Manufacturer Narrative

Device evaluation: service repair noted watertightness is not maintained due to breakage of the insertion part serpentine tube.The insertion part serpentine is crushed due to an external factors.In addition, the forceps stopped was found scraped.Wrinkles found in the insertion part due to external factors.Abnormal appearance of soft part of insertion part was observed.There is play in the curved tube.The bending angle is insufficient due to the elongation of the angle wire.The insertion angle wire found worn, frayed.There is an abnormal noise due to damage to the angle lever due to external factors.The curved rubber adhesive is missing.The video cable found crushed.There are scratches on the operation part, ud (up/down) plate, the angle lever, video cable, video connector , light guide connector, up/down angle fixing lever.There is an abnormal noise due to damage to the angle lever due to external factors.The curved rubber adhesive is missing.The video cable found crushed.Evaluation findings found watertightness not maintained (leakage) due to breakage of the insertion part serpentine tube.The customer reported issue could be confirmed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The investigation confirmed that the biopsy port section of the device was scratched.A review of the device history record found no deviations that could have caused or contributed to this problem.The investigation did not establish a definitive root cause for this device issue.However, the issue was potentially caused by mishandling or stress exerted on the device.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14722532
• MDR Text Key: 302856301
• Report Number: 8010047-2022-10208
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310508
• UDI-Public: 04953170310508
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

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: Other
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• 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