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 device was returned to olympus and evaluated.The reported problem was confirmed.When the scope was tested, leaking was noted due to a cut in the light guide tube.In addition, the bending section c-body was found detached.Based on similar reported complaints, the most likely cause of the reported event can be attributed to user handling or technique.The device instructions for use contains the following warning statements: warning: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.Warning: do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, video cable, video connector, and light guide connector.The endoscope may be damaged, and water leaks and/or breakage of internal parts like the image sensor cable can result.

Event Description

A user facility reported their olympus cysto-nephro videoscope failed the leak test during reprocessing.There was no patient injury or harm associated with the reported problem.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer's investigation and device history record (dhr) review.A dhr review was performed.There were no abnormalities in manufacturing found and it was verified the device was manufactured in accordance with documented specifications and procedures.The legal manufacturer was unable to determine a conclusive root cause for the reported problem.However, the legal manufacturer's investigation confirmed that the likely cause of the leak was due to user handling.The detached distal end, identified upon device evaluation, was determined by the legal manufacturer likely associated with adhesion strength.An investigation is ongoing related to the root cause of the finding of "detached distal tip.".

• 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: 10224269
• MDR Text Key: 224633070
• Report Number: 8010047-2020-03836
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170310461
• UDI-Public: 04953170310461
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

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: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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