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

Model Number URF-P6

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation, the reported issue was confirmed.Excessive broken fibers were found in the image.Also, the skeleton of the bending section was found broken with damage to the bundles and fibers.No other issues were found during the inspection.If additional information is provided a supplemental report will be filed.

Event Description

A user facility reported that their fiberscope had broken fibers.No patient involvement or injuries were reported.No additional information has been obtained.

Manufacturer Narrative

Based on the legal manufacturer¿s investigation, the dhr was reviewed and there were no problems found during the manufacturing of the device.The device met all specifications at the time of shipment.The device was purchased (b)(6) 2018 and has undergone 6 repairs performed by olympus in the past year.This facility has not reported any similar complaints for this device.There has been one other similar complaint reported by another facility.

• 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: 10566298
• MDR Text Key: 207916027
• Report Number: 8010047-2020-06717
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1