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Model Number URF-P6
Device Problems Material Separation (1562); Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2021
Event Type  malfunction  
Manufacturer Narrative
During the evaluation at an olympus service center, the reported issue was confirmed. The image was intact but had some loss of functionality due to a broken fiber from physical stress. The device was missing about twenty (20) centimeters (approx. Eight (8) inches) of insertion tube. In addition, the insertion tube and the port were coming apart. The investigation is ongoing. A supplemental report will be submitted upon completion of the investigation.
Event Description
It was reported to olympus while using the uretero-reno fiberscope, there were spots in the image with one center point. No patient harm was reported. During the evaluation of the device, a malfunction of broken metal wires sticking out from the inside on the non-bending section of the insertion tube was noted. This report is to capture the reportable malfunction of broken metal wires sticking out from the inside on the non-bending section of the insertion tube noted at estimation.
Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the reporter.
Event Description
Additional information was provided by the reporter. The issue was found during and after a therapeutic laser ureterolithotripsy procedure. There was a twenty-five (25) minute delay. There was no information available regarding the status of the patient during the delay period. The intended procedure was completed with same device. The device was inspected prior to use with no findings.
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation. The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria. No abnormalities were found. The root cause of the issue could not be conclusively specified. From the following findings, it was likely the user cut the insertion section: spots at the center of the image were reported by the user. 20 cm of insertion section was missing. The device inspection result showed that the insertion section was cut by a human. In a similar complaint, a part of the insertion section was missing when the device arrived because the user had cut it. The instructions for use (ifu) provides the following guidelines: 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, forming objects, or other irregularities.
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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 Key12040620
MDR Text Key273639938
Report Number8010047-2021-07832
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse