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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); Poor Quality Image (1408)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2018
Event Type  malfunction  
Manufacturer Narrative
The subject device has not been returned to omsc but was returned to olympus (b)(4). The evaluation of the subject device by (b)(4) confirmed following. There was an air leakage from the instrument channel. When it was angulated towards one direction, meandering occurred at the bending section. Furthermore, when it was angulated towards the opposite direction, some resistance was felt causing that the bending section did not return straight. The endoscopic image became foggy. The exact cause could not be determined at present, because the evaluation is in progress. Omsc reviewed the manufacture history of the subject device and confirmed no irregularity. If significant additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed that the physician of the user facility noticed that the shape of the bending section of the subject device became abnormal during stone removal procedure for a kidney calculus. The user also reported that there was an air leakage from the insertion section and the endoscopic image became foggy. The subject device was replaced with another similar device and the procedure was completed. There was no report of patient injury associated with this report.
 
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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 Key7904851
MDR Text Key122635824
Report Number8010047-2018-01833
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
Report Date 09/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2018
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 Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2018
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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