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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-V2
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2018
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to omsc for evaluation. The evaluation confirmed that air leak from the bending section of the device and the metal part was exposed from the bending section rubber. Also, omsc reviewed the manufacturing history of this device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined at this time, since the evaluation has not been completed. If additional information is received, this report will be supplemented. In an effort to prevent bending section damage, the instruction manual of the device contains several statements; ¿do not insert the insertion tube with excessive force into the ureter or calix. The bending section may be damaged. ¿ ¿do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved. The bending section may be damaged. Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc. Do not insert the insertion tube with excessive force and twist. ¿.
 
Event Description
Olympus medical systems corp. (omsc) was informed that during a therapeutic procedure, the user facility found that the bending section of the subject device broke. The device was replaced with another device of the same model and the procedure was completed. There was no patient injury associated with this report.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the evaluation result for the subject device by olympus medical systems corp. (omsc). The evaluation confirmed the bending tube of the device broke. In the past causal investigation by omsc, it was confirmed that the bending tube breakage occurred when urf-v2 was repeatedly pushed against the wall under the condition that the tip of urf-v2 was in contact with a kidney wall. Therefore, it is considered that the bending tube breakage of this report possibly occurred by the same mechanism. As for handling of the endoscope with excessive force, the ¿instructions for safe use¿ of the device contains following statements; ¿do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved. The bending section may be damaged. Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc. Do not insert the insertion tube with excessive force and twist. Do not insert the insertion tube with excessive force into the ureter or calix. The bending section may be damaged. ¿.
 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key7463398
MDR Text Key107101220
Report Number8010047-2018-00751
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/21/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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