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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-P6R
Device Problem Mechanical Jam (2983)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The scope has not returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. To mitigate against patient injury, both the scope operation manual and instructions for safe use documents contain warnings and directions to address loss of angulation: ¿if the angulation control mechanism or any other part of the system is not functioning properly, stop the procedure immediately and place the up/down angulation lock in the free ¿f ¿ position. Then carefully withdraw the endoscope while observing the endoscopic image. If the endoscope cannot be withdrawn from the patient smoothly, do not attempt to forcibly withdraw it. Rather, withdraw the endoscope carefully. If the endoscope cannot be withdrawn from the patient, consider removing it through open surgery and take proper measures. ¿ also, ¿do not insert the insertion tube with excessive force into the ureter or calix. The bending section may be damaged. ¿ a review of the scope service history shows no olympus service performed on the scope since at least 2016.
 
Event Description
Olympus was informed that during a lithotripsy procedure, the scope device was in use with separate unknown model guidewires and an holmium pf-120 laser lithotripsy device. When the laser was applied, a spark occurred. The surgeon pulled back the guidewire and then another spark occurred. It was reported that the outside of the tip of the scope pulled back, and then the scope could no longer be angulated completely. The angulation problem had not been seen until after use of the laser. The scope then became stuck in the patient. The surgeon was still able to withdraw the scope from the patient, however the left ureter became torn and urine leakage developed. The patient received stents and a nephrostomy tube during the procedure, and has since gone home with the nephrostomy tube implanted. It was reported that the scope had been inspected prior to use, with no anomalies found.
 
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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
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8188063
MDR Text Key131168593
Report Number2951238-2018-00787
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6R
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/20/2018 Patient Sequence Number: 1
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