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

Model Number CYF-VH

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The referenced scope was returned to the service center (oci) for evaluation of the reported failed leak test.The scope failed the leak test at the instrument channel.The distal end was found loose/detached screw.The bending cover adhesive was cracked.The bending section was removed and moisture was observed.Additionally, the angulation/control knobs were not working due to heavy moisture and corrosion found inside the control body.There were scratches, chemical damage and discoloration found on the insertion tube.The light guide tube was worn with scratches.The root cause cannot be determined at this time as the investigation is ongoing.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was informed that during reprocessing, the cysto-nephro videoscope failed the leak test.No harm or patient injury was reported.

Manufacturer Narrative

This report is being submitted to report the investigation findings.The instructions for use (ifu) shipped with the device provides the user with the following information related to the reported issues: chapter 3 preparation and inspection the equipment prepared before using this endoscope and procedures for the inspection of the endoscope and equipment are described in this chapter.3.1 the workflow of preparation and inspection the workflow of preparation and inspection is shown below.Before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in chapter 5, ¿troubleshooting¿.If this endoscope malfunctions, do not use it.Return it to olympus for repair as described in section 5.4, ¿returning the endoscope for repair¿.Warning ·using an endoscope that is not functioning properly may compromise patient or operator safety and may result in more severe equipment damage.A review of the device history record for the device was completed and it was confirmed there were no abnormalities in the manufacturing of the device.Conclusion: the root causes could not be identified.Based on the investigation results, the probable causes are shown below.Physical damaged noted on the device: an external force was applied to the device; or age deterioration foreign objects were stuck in a movable part of the control section, causing failure to move the angle control lever, probable cause: foreign object adulteration due to leak or corrosion due to the intrusion of water.

• 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: 10757107
• MDR Text Key: 224661174
• Report Number: 8010047-2020-08305
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411250
• UDI-Public: 04953170411250
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2014
• 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