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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-P6
Device Problems Break (1069); Display Difficult to Read (1181)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2020
Event Type  malfunction  
Manufacturer Narrative
The subject devices have not been returned to omsc but were returned to olympus (b)(4) (oekg) for evaluation. In the evaluation of oekg the following was confirmed; leak from the a-rubber bending section bending section broken (no external protrusion) image guide bundle was damaged omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. The user admitted that he pushed the device with excessive force and it led to the breakage. If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed that during the retrograde intrarenal surgery (rirs) using the subject device, the bending section of the subject device was broken and the endoscopic image got abnormal. The user replaced the subject device to another one and completed the procedure. There was no report of patient injury associated with the event.
 
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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 Key9761921
MDR Text Key222561064
Report Number8010047-2020-01536
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 02/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
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 Received01/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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