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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-V
Device Problems Mechanical Problem (1384); Aspiration Issue (2883)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This device referenced in this report has been returned to olympus medical systems corp. (omsc) for evaluation. During the evaluation by omsc, it was confirmed that there was a hole on the instrument channel at 47 cm from the distal tip of the subject device, and air leak was found at the point. Furthermore, there were shavings piled up inside the instrument channel which clogged the channel. Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity. Based upon the evaluation, it was concluded that the instrument channel might be shaved due to inserting endo therapy accessory forcibly, and the shavings clogged the instrument channel which caused the reported event. The instruction manual contains several warning statements in an effort to prevent channel damage. ¿inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories, causing some parts to become detached and/or causing patient injury. " "straighten the endoscope¿s insertion tube as much as possible to avoid damage to the instrument channel while inserting the endotherapy accessory into the channel. ¿.
 
Event Description
Olympus medical systems corp. (omsc) was informed that during a tul (transurethral ureterolithotomy) procedure, a guidewire and a laser probe could not pass through the instrument channel of the subject device. The user replaced the subject device with another device and the procedure was completed. There was no injury associated with this event reported.
 
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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 Key7243322
MDR Text Key99796246
Report Number8010047-2018-00144
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2012
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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