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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2018
Event Type  malfunction  
Manufacturer Narrative
As part of our investigation, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained. The user facility further reported that the reported scope will be sent to a non-olympus third party entity for evaluation and service. It is unknown if the scope will be returned to olympus for evaluation. A review of the device service history was performed and found that the scope was purchased on (b)(6) 2018 and was never returned to olympus for evaluation. Based on similar reported events and investigation findings, the cause of the reported device damage is likely related to the operator¿s technique. The ¿instructions for safe use¿ provides several warning statements in an effort to prevent equipment damage and patient injury. ¿if any of the following conditions occur during an examination, immediately stop the examination and withdraw the endoscope from the patient. If the up/down angulation control lever does not move. If the angulation control mechanism is not functioning properly. Visually inspect the bending section for no metallic parts protruding from the bending section. Visually inspect the bending section for bends, twist, or other irregularities while the bending section remains straight. Visually inspect the bending section for abnormal bending shape, or other irregularities. Continued use of the endoscope under these conditions could result in patient injury, bleeding, and/or perforation".
 
Event Description
Olympus was informed that during an unspecified ureteroscopy procedure, the tip of the scope broke off into pieces inside the patient. A non olympus holium laser was reportedly used with the olympus ureteroscope during the procedure. The physician was unable to retrieve all of the device fragments from the patient and will be scheduling another endoscopic procedure to retrieve the remaining device fragments. It was also reported that if the follow up endoscopic procedure is unsuccessful, the physician will then schedule an open surgery. There was no patient injury reported.
 
Manufacturer Narrative
Olympus received a voluntary medwatch report (mw5076824) on may 4, 2018 indicating that the reported event occurred during a laser lithotripsy and ureteral stent placement. It was also reported that an access sheath was advanced approximately in the middle of the pelvic bone area, allowing the ureteroscope to advance into the ureter over a wire, allowing stone visualization. A stone was lasered into multiple small fragments. The scope could not be retracted; however the surgeon was able to remove the access sheath. A rotating motion was then performed on the scope and the scope was able to be removed from the patient. As a result, approximately 2cm of the tip of the scope broke off and remained inside the patient.
 
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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
MDR Report Key7478078
MDR Text Key107919978
Report Number2951238-2018-00294
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P5
Device Catalogue NumberURF-P5
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/04/2018
Is This a Reprocessed and Reused Single-Use Device? No

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