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

Model Number CYF-V2

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The damaged device has not been returned to olympus for repair and evaluation.Based on the information provided to olympus by the user facility, the cause of the damage to the scope has been assigned to the user due to failure to follow the instructions for use reprocessing instructions.The user facility stated the cap was not attached during sterilization.A sterilizer (unknown manufacturer, model and serial number) is being used to reprocess the endoscopes.The instructions for use provides the following caution statement when performing sterilization: "caution: attach the eto cap to the venting connector before sterilization.If the eto cap is not attached to the endoscope during sterilization, the vacuum created within the sterilization chamber can rupture the covering of the bending section.".

Event Description

A user facility reported to olympus that their videoscope was damaged due to incorrect reprocessing.The reported damage was described as "the insulation goes past the distal tip." the issue was found on inspection during preparation for a procedure.The type of intended procedure is unknown.It is unknown if the intended procedure was completed.There was no patient injury associated with the problem reported to olympus.Per the user facility, the incorrect processing was due to a new person in the reprocessing area and the individual was not aware of the correct scope reprocessing procedures.The scope was not cultured.No patient impact associated with the incorrect reprocessing and scope damage was reported to olympus.The user facility stated that the damage was limited to 1 scope.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer device history record (dhr) review.Upon review of the dhr for the involved device, it was confirmed that there were no abnormalities, special adoptions, or variations in the manufacturing process.

• Brand Name: VISERA 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: 10006364
• MDR Text Key: 222560497
• Report Number: 8010047-2020-02409
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

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-V2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/07/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 06/05/2020
• Supplement Dates FDA Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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