MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information is not yet received for this event.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date is not available.The device was returned for the issue of the bridge port coming out of the instrument cannel.The device was returned without any missing part or detached part including the biopsy port.Unable to duplicate the user's request.The user¿s complaint was not confirmed.Upon inspection and testing, incidental findings were decreased lighting from the light guide lens, which had some corrosion, and a trace of fluid invasion from the eyepiece.

Event Description

As reported for this event, during preparation for use for an unknown procedure the bridge port of the device came out of the instrument channel.There is no patient involvement and no harm reported to any patient.

Manufacturer Narrative

Additional information has been received for this event.This supplemental report is being submitted to provide this information.Please see the updates in sections: b3, g4, g7, h2, and h10.The device was pressure checked and showed no issues prior to use.After the scope was used by the physician and procedure completed with it, the cleaning process commenced.As cleaning was being done, initial reporter had been informed that the bridge port came out.Upon observation, during cleaning, it was noted that the bridge port was not seated any longer.The particulars of how it had happened are not shared.Steps for cleaning are: the scope is wheeled into the lab on a cart, light cord is removed and water is taking off the scope, bridge is removed, a visual inspection is done.The scope is then placed in the enzymatic cleaner, channel brush is put through the whole length of the scope several times to clean any debris.A small channel brush is used at the bridge port then the channel is flushed using a 60 cc syringe.The scope is soaked for two minutes and then flushed again.The scope is then ready to be disinfected again.Disinfecting is done by pressure testing the scope soaking in aldohol for 10 min then moved to first clean water and flushed with 60 cc syringe and soaked for one minute.The scope is then moved to the second water and the same is repeated for the second water and again in the third water.The scope is removed, set up on sterile tray for the next patient.The scope is stored in a cupboard.Scopes are hung with eye piece on top and channel hanging down scope doesn¿t touch anything but the bracket that holds the scope.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.The root cause of the bridge port coming out of the instrument cannel cannot be determined.However, it may have happed as follows: this phenomenon may have occurred because an excessive external force was applied when attaching or detaching the t-tube to or from the t-tube mounting cap.There is no external damage such as scratches on the fitting cap of the t-tube.Therefore, it is highly likely that this phenomenon occurred at the time of contact of the t-shape tube.The instructions for use includes the following statements: chapter 9 storage.9.1 storage.Prior to storage, detach all removable parts from the endoscope.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10951441
• MDR Text Key: 226702576
• Report Number: 8010047-2020-09867
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1