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Model Number URF-V2
Device Problems Break (1069); Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2020
Event Type  malfunction  
Manufacturer Narrative
Due diligence was executed for this event. There is no additional information for patient and event available as yet. The device has been returned and a device evaluation completed for it. The user¿s complaint was confirmed. A visual inspection was performed on the received condition of the device and noted the bending section skeleton tab is protruding from the bending section cover at the insertion tube side. The bending section cover was then removed and the skeleton is noted detached/broken with no signs of any sharp edges. The instruction manual states the following; ¿do not twist or bend the bending section with your hands¿. Additionally, the instructions for safe use manual indicate that, damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment. The scope had a 28 f (overhaul) 5/23/2019. In addition, there is leak inside the biopsy channel. The biopsy channel had a leak and noted evidence of tear/torn marks on the channel wall at the distal end side that cause the leak.
Event Description
As reported for this event, during procedure the device had a cracked insulation at the tip. There was no adverse impact to the patient reported.
Manufacturer Narrative
There is more information on the device evaluation. This supplemental report is being submitted to provide this information. The device history review confirmed that device met all the standards required prior to the device being shipped out. The bending tube design has been updated to preclude any possibility of damage to the patient body even if the bending tube were damaged. Despite due diligence, there has been no additional information available for the details of the event. The cause of the damage is likely excessive pushing force applied while the bending section was bent. The instructions for use (ifu) contains following description regarding a-rubber breakage; abnormalities can be detected by pre-use inspection: ¿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. ¿ the instructions for use (ifu) contains following description regarding the bending tube broken; such breakage can be prevented by usage per the ifu: ¿important information ¿ please read before use: never perform angulation control forcibly or abruptly. Never forcefully pull, twist, or rotate the angulated bending section. Patient injury, bleeding, and/or perforation may result. It may also become impossible to straighten the bending section during an examination. ¿.
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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 Key10058955
MDR Text Key211037908
Report Number8010047-2020-02707
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 other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2020
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 Manufacturer04/16/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/20/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse