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  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation noted break of angle wire.Service repair noted the bending angle is insufficient due to the elongation of the angle wire.There is an abnormal noise due to damage to the angle lever due to external factors.The customer reported issue of bad angle could be confirmed.Furthermore, inspection noted forceps cannot be inserted smoothly due to the collapse of the forceps channel due to an external factor the forceps stopper scraped due to an external factor.Additionally, the following findings during device inspection and evaluation were noted: the channel cleaning brush cannot smoothly inserted due to the crushing of the forceps channel due to external factors.There are scratches on the operation part due to external factors.There are scratches on the switch box due to external factors.There are scratches on the universal code due to external factors.There are scratches on the grip due to external factors.The angle lever scratched due to external factors.Scratches found on the ud plate due to external factors.There are scratches on the video cable due to external factors.Wrinkles found on the video cable due to external factors.The video connector scratched due to external factors.The lg (light guide) connector scratched due to external factors.The video connector scratched due to external factors.Scratches are found on the ud angle fixing lever (sp) due to external factors.The index peeling of the operation part is recognized.The insertion part serpentine is crushed due to an external factor.Wrinkles in the insertion part due to external factors observed.The curved tube crushed due to an external factor.There is play in the curved tube.The curved rubber adhesive is missing.Due to an external factor, the operation part side of the universal cord part cut off.The index peeling of the grip part noted.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer reported with an issue of angle defect (bad angle) (angulation malfunction).The issue found during an unknown event.There was no patient harm, no user injury reported.Device evaluation found the forceps stopper is scraped (channel/instrument malfunction) due to physical load, physical stress.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the forceps stopper clamp was shaved and was caused by the same cause as the other fractures.It is unable to be determined whether the shaving was due to stress, handling or other factors.Therefore, the root cause could not be identified.Olympus will continue to monitor field performance for this device.

Event Description

Additional details have been requested regarding the reported event.At this time, no additional information has been provided.

Manufacturer Narrative

This supplemental report is being submitted because additional information regarding the event was received.

Event Description

The initial medwatch report was submitted for the malfunction found during evaluation (forceps stopper is scraped due to physical load, physical stress).The following additional information was received from the customer: the device was inspected before use and no abnormalities were found.There was no patient adverse event.

• 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: 14918262
• MDR Text Key: 303802246
• Report Number: 8010047-2022-11339
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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: Other
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 07/27/2022; 10/13/2022
• Supplement Dates FDA Received: 08/25/2022; 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2014
• 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