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

Model Number URF-P7

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the endoscopic image became foggy during a therapeutic retrograde intrarenal surgery (rirs) procedure using the subject device.The user facility completed the procedure using a similar device.The user facility used a non-olympus holmium laser (lumenis, 120h moses).There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, there is a possibility that this phenomenon was attributed to the intrusion of water into the inside of the objective lens or light guide lens due to the deterioration of the adhesive by the reprocess.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to omsc but was returned to olympus europa se & co.Kg.(oekg).In the evaluation of oekg the following was confirmed, the endoscopic image was unsharp.Also, the subject device passed leak test and there was not signs of humidity inside of the subject device.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

• 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: 9731323
• MDR Text Key: 221585618
• Report Number: 8010047-2020-01459
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1