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Model Number URF-V2
Device Problem Fluid Leak (1250)
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, a leaking on the a-rubber at the joint near the metal band was found. A sharp broken metal was sticking out on the bending section. The image was inspected and looked clear with all the camera switches working properly. No other issues were found during the device inspection. If additional information is obtained a supplemental report will be filed.
Event Description
A user facility reported that a videoscope failed the leak test during reprocessing. No patient involvement or injuries were reported. No additional information has been obtained.
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation. A review of the device history record found no deviations that could have caused or contributed to the reported issue. Based on the results of the investigation, the cause of the event was breakage of the bending tube. It is likely that operation by the user and application of excessive force caused the bending tube breakage. Based on the review of the instructions for use, the following statements could prevent the suggested event identified: 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. 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. The instructions for use also contains information regarding the detection of the reported issue: 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.
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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 Key11112562
MDR Text Key233304348
Report Number8010047-2021-00817
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse