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Model Number URF-V3
Device Problem Failure to Clean Adequately (4048)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
During inspection and testing, service found debris at a void in the adhesive on the bending section cover due to insufficient reprocessing.A review of the device history record found no deviations that could have caused or contributed to the reported event.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the foreign material was attached to the device due to the adhesive cracking from user handling.The insertion section (metal part) around the crack was corroded and rust was generated.The rust was then specified as debris.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following instruction, which may help to prevent the issue: ¿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.¿ olympus will continue to monitor field performance for this device.The report of a leak was confirmed during testing.The channel leaked due to being scraped by repeated insertion and withdrawal of brushes and accessories.The report of marks on the distal end were not confirmed.There was corrosion and rust on the distal end of the device and the lens but no melting or black marks were observed.In addition, the adhesive on the bending section cover was cracked and peeling, the bending section cover was damaged and metal was exposed but not protruding, and there was a tear mark near the distal end side and middle of the interior of the biopsy channel.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.
Event Description
The customer reported that, during reprocessing, the subject device failed leak testing.Black marks were also noticed at the distal tip and the case was slightly melted in that area.The subject device was sent to an olympus service center for evaluation.During inspection and testing, service found debris at a void in the adhesive on the bending section cover.This report is being submitted for the malfunction found during evaluation (foreign material).There was no harm or user injury reported due to the event.
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Brand Name
Type of Device
Manufacturer (Section D)
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA  965-8520
Manufacturer Contact
masaharu hirose
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8-520
JA   965-8520
MDR Report Key15141822
MDR Text Key304879018
Report Number9610595-2022-00500
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170403385
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberURF-V3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2022
Was the Report Sent to FDA? No
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1