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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
As part of our investigation, olympus followed-up with the user facility via telephone and in writing in an attempt to obtain additional information regarding the reported event, but no information was obtained. The referenced device was returned to olympus for evaluation. The evaluation, found the bending section was broken with sharp metal exposed from the bending section skeleton. The scope failed the leak test from a hole on the bending section cover. In addition, the image has excessive broke image guide bundle breakage (black dots), the angulation low is below specification. Furthermore, the insertion tube and bending section cover/glues are non-olympus parts/repairs. Based on the evaluation findings, the most probable cause of the reported event could be attributed to improper maintenance and or handling. The user facility declined repairs and the scope was returned to the user facility unrepaired. A review of the scope's instrument history record, indicates the scope was purchased on march 28, 2018 with no repair history. As a preventive measure, the instruction manual states, the probability of failure of the endoscope and ancillary equipment increases as the number of procedures performed and/or the total operating hours increase. In addition to the inspection before each procedure, the person in charge of medical equipment maintenance in each hospital should inspect the items specified in this manual periodically following regulations, guidelines, etc. Required of you. An endoscope with an observed irregularity should not be used, but should be inspected by following section 5. 2, ¿troubleshooting guide¿. If the irregularity is still observed after inspection, contact olympus. The instruction manual also provides caution which states, ¿this instrument does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or operator injury and/or equipment damage may result. Equipment that has been disassembled, repaired, altered, changed, or modified by persons other than olympus¿ own authorized service personnel is excluded from olympus¿ limited warranty and is not warranted by olympus in any manner. ¿.
 
Event Description
Olympus was informed that the user facility's operating room nurse manager tested the scope prior to use and observed the scope was broken. It was not specified when the breakage occurred. There was no patient involvement reported with the subject scope.
 
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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 Key8434886
MDR Text Key141329818
Report Number2951238-2019-00557
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 company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 03/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/21/2019
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

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