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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES URETERO-RENO FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. OES URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P5
Device Problem Difficult to Advance (2920)
Patient Problem Injury (2348)
Event Date 09/13/2018
Event Type  Injury  
Manufacturer Narrative
The urf-p5 device has not been returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. To mitigate against patient injury during use, the device instruction manual contains several warning statements regarding device operation: ¿never perform angulation control forcibly or abruptly. ¿ ¿never perform angulation control or insertion/withdrawal of the endoscope¿s insertion tube without viewing the endoscopic image. ¿ ¿never insert or withdraw the insertion tube abruptly or with excessive force. ¿ and ¿never insert or withdraw the endoscope while the endo-therapy accessory extends from the distal end of the endoscope. ¿ the instruction manual also has directions for pre-procedure inspection and operational verification of the movement of the scope device. As a preventive measure in the event of device malfunction, the instruction manual also recommends ¿be sure to prepare another endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction. ¿.
 
Event Description
One of 2. Olympus was informed that during a diagnostic ureteroscopy, the surgeon was having trouble accessing the left distal ureter using the urf-p5 device. The device was removed from the patient and a separate long rigid ureteroscope was substituted. While using the replacement ureteroscope, the surgeon noticed that the ureter had detached from the kidney. Afterwards the patient was informed that a separate laparoscopic intervention is indicated to repair the avulsed ureter.
 
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Brand NameOES URETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key7896397
MDR Text Key120964716
Report Number2951238-2018-00556
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340307
UDI-Public04953170340307
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberURF-P5
Device Catalogue NumberURF-P5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated by Manufacturer? Yes
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: 09/20/2018 Patient Sequence Number: 1
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