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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P7R
Device Problem Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2019
Event Type  malfunction  
Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp. (omsc) but was returned to (b)(4). (b)(4) evaluated the subject device and confirmed that black dots were displayed on the endoscopic image of the subject device and there was a crack on the lens of the subject device. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed that during a retrograde intrarenal surgery, black dots were displayed on the endoscopic image of the subject device. It was reported that the user facility was using a laser device when the event occurred. The user facility changed the subject device and the procedure was completed with another device. There was no report of patient injury associated with the event.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information. On august 6th, 2019, olympus medical systems (b)(4) additionally evaluated the subject device and the additional evaluation results were as follows; there was a leak from the object lens. There was a burn mark at the distal end. There was corrosion inside the bending tube. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. Considering the burn mark at the distal end, it is likely that the image fiber breakage, lens cracking, and leakage from the object lens occurred due to erroneous irradiation of the laser inside the subject device. It is surmised that the reported event occurred due to the image fiber breakage. The instruction manual of the device has already warned as follows; do not irradiate the laser without viewing the tip of the laser probe and the aiming beam in the endoscopic image. This may cause patient injury, and the instrument channel may be damaged. Do not withdraw the laser probe while irradiating the laser. Patient injury and/or endoscope damage may occur.
 
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Brand NameURETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
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 Key8854247
MDR Text Key195245827
Report Number8010047-2019-02810
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P7R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/25/2018
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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