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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 Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/15/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined. If additional information becomes available at a later time, this report will be supplemented. This event has been reported by the importer on mdr# (b)(4).
 
Event Description
Olympus received medwatch 5096215. It was reported that during the beginning of a cystoscopy with bilateral retrograde pyelograms, bilateral ureteroscopy, laser lithotripsy and stent, while the physician was using the ureteroscope, the laser did not fire correctly. Subsequently, the physician switched to another fiber and when lasering the ureter, a piece of the fiber broke off into the patient. Per the physician, this was possibly due to the ureteroscope. Retrieval was attempted to no avail as the fragment fell off the basket during removal. The physician was unable to find the fragment. It was noted the same ureteroscope was used to complete the procedure which was delayed by minutes[sic]. Per the clinician, patient follow-up appointments indicate no negative outcomes from the procedure. No further attempts to remove the fragment are required.
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-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 Key10619895
MDR Text Key209598006
Report Number8010047-2020-07151
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
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 Received11/17/2020
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 Initial

Patient Treatment Data
Date Received: 10/02/2020 Patient Sequence Number: 1
Treatment
200 MICRON LASER FIBER; 365 MICRON LASER FIBER
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