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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 Problems Break (1069); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This device referenced in this report has not been returned to olympus medical systems corp.(omsc) for evaluation, but was returned to olympus regional repair center in europe (rrc).Rrc removed the bending rubber of the subject device and confirmed a crack in the bending tube.From our causal investigation result, it was confirmed that under the condition where the distal end of the scope comes in contact with an inner wall of a kidney, if the scope is repeatedly further pushed, the bending tube breakage occurs.Therefore, the bending tube breakage in this report is considered to have occurred in the above mechanism.The instruction manual contains several statements in an effort to prevent bending section damage.¿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 an unspecified procedure, the bending tube of the subject device broke and the user replaced the subject device with another device of the same model.The procedure was prolonged approximately 5 minutes and was completed.It was also reported that there was no metal parts protrusion from the bending rubber of the subject device.There was no patient injury associated with this event reported.
 
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Brand Name
URETERO-RENO VIDEOSCOPE
Type of Device
URETERO-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 Key7265885
MDR Text Key100268936
Report Number8010047-2018-00217
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
PK072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberURF-V2
Other Device ID Number04953170343582
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/17/2018
Initial Date FDA Received02/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number2429304-12/12/2016-041C
Patient Sequence Number1
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