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Model Number URF-P6
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
The service center was informed that the uretero-reno fiberscope was returned for a reported image problem.During inspection and testing, the scope was found to have metal protruding from the bending section cover.There was no patient injury or harm reported to olympus.
Manufacturer Narrative
The evaluation found the a hole and protruded (metal) skeleton from the bending section cover.The reported image issue was confirmed as the image has excessive broken fibers (black dots).Additionally, the scope failed the leak test due to a large leak from the instrument channel at the distal end.The bending section cover glue is chipped with exposed threading.The objective lens has sunk down and the eyepiece body is discolored.The scope was last serviced via repair on (b)(6) 2019.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the cause of the suggested event was breakage of bending tube, which was due to user handling that applied excessive stress to bending section.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "precautions : perform a leakage test on the endoscope after each precleaning procedure.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.Use of a leaking endoscope may also pose an infection control risk.Inspection of the endoscope : inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.Do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved.The bending section may be damaged.Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc.Do not insert the insertion tube with excessive force and twist.Do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged." olympus will continue to monitor the field performance of this device.
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Brand Name
Type of Device
Manufacturer (Section D)
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
MDR Report Key13287734
MDR Text Key284027676
Report Number8010047-2022-01619
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340802
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberURF-P6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2021
Was the Report Sent to FDA? No
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1