MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE

Model Number URF-P6

Device Problems Poor Quality Image (1408); Device Contamination with Chemical or Other Material (2944); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Due diligence was executed for this event.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, during reprocessing black stuff came out of the channel.There was also distorted image.No other devices were involved or replaced in this event.The device was inspected prior to use when the distorted image was noticed.No damage or abnormalities were observed.The seepage of the adhesive was observed when the device was being cleaned.The distorted image was unable to be elaborated on.No alarms, alerts, warnings or errors were received.The device is reprocessed in a sterrad.The device is being stored in a container, wrapped on a shelf.There was no visual damage to the bending section of the scope.The intended procedure was cystoscopy and there was no delay or impact on it by the event.Another device was used for that procedure and procedure completed.The procedure not being part of the event, no patient or procedure details are provided nor was the patient affected or harmed by it.

Manufacturer Narrative

The device is not returned.As such, an actual device evaluation is not performed.An evaluation is done based on historical records and communication.This supplemental report is being submitted to provide this information.The device history record review confirmed that the device was shipped in accordance with specifications.There is no repair history for the device on record.Reported issue for this device is foreign material falling off from the channel.There was no damage or abnormality on the scope.The foreign matter is not a part derived from the scope.Component of the foreign material is not known.As such, the foreign material cannot be identified.It is possible that a part of the scope accessories or the cleaning tools for reprocessing used by the user have inadvertently entered into the channel.The user properly detected the issue per the instructions for use guidelines.The instructions for use includes the following statements: 1.7 reprocessing before patient procedure : confirm that the endoscope and accessories have undergone proper reprocessing following their last use and that they have been stored properly.Check the storage period of reprocessed endoscopes, and check for surface contamination (e.G., dust).Check the expiration date marked on all items and check for tears or breaches in the sterile packaging.If there are any doubts or questions concerning whether a device is contaminated, reprocess it again following the instructions given in this manual.5.5 manually cleaning the endoscope : brush the channel : be sure to thoroughly brush the inside of the instrument channel, the instrument channel junction, and the instrument channel port of the endoscope.Insufficient brushing may pose an infection control risk.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10748651
• MDR Text Key: 219567342
• Report Number: 8010047-2020-08247
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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: No Information
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1