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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V2R
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to service center for evaluation. The user¿s complaint has been confirmed. A visual inspection was performed on the returned device and found the bending section skeleton broken near the insertion tube side. At that same location, the bending section was also missing (10 percent) and the missing portion has not returned. The bending section skeleton was not protruding through since it was already exposed due to the missing bending section cover piece. Service center proceeded to remove the remainder of the bending section cover, which revealed a fully separated bending section that was producing sharp edges, approximately 70mm from the distal end. Additionally, six out of the twelve bending section supports pins were lifted causing rough edges. The scope was recently refurbished (28f) on (b)(6) 2019. Based on the evaluation, the likely cause of the bending section skeleton breaking is due to excessive force and/or stress attributed to mishandling. The ¿instructions for safe use¿ provides several warning statements in an effort to prevent equipment damage and patient injury; ¿do not twist or bend the bending section with your hands, equipment damage may result¿. 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.
 
Event Description
The service center was informed that during reprocessing, right after use, the scope was noted to be broken (the tip was bent). The procedure went fine with the scope and there were no patient injury reported. A leak test is performed after each use.
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-RENO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
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
426425177
MDR Report Key8846504
MDR Text Key216159407
Report Number8010047-2019-02772
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 07/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/03/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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