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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS AMERICA OLYMPUS FLEXIBLE URETEROSCOPE

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OLYMPUS AMERICA OLYMPUS FLEXIBLE URETEROSCOPE Back to Search Results
Model Number URF TYPE P5
Device Problem Retraction Problem (1536)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Event Description
Retained portion of ureteroscope during laser lithotripsy and ureteral stent placement. Pt underwent a right ureteroscopy with lithotripsy. An access sheath was advanced to the level of the mid pelvic bone allowing the ureteroscope to advance into the ureter over a wire. This allowed stone visualization. A stone was lasered into multiple small fragments. Attempt to retract the scope was unsuccessful. Surgeon able to remove the access sheath, but the scope could not be retracted. The scope could move up but not back, a rotating motion was then done, and this rotation allowed the scope to be removed. However the last 2 cm of the ureteroscope broke off and remained in the pt.
 
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Brand NameOLYMPUS
Type of DeviceFLEXIBLE URETEROSCOPE
Manufacturer (Section D)
OLYMPUS AMERICA
2400 ringwood ave
san jose CA 95131
MDR Report Key7471911
MDR Text Key106954185
Report NumberMW5076824
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF TYPE P5
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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