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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
The scope was returned for service to evaluate the reported ¿broken bending skeleton, damage distal tip¿. A visual inspection was performed on the bending section cover and was unable to find any signs of protruding from the bending section cover and the scope passed the leak test. However, the bending section skeleton was observed to be deformed underneath the bending section cover. The bending section cover was removed and the bending section skeleton tab was fully broken/detached at the proximal side of the bending section. Additionally, there was no significant evidence of sharp areas noted with the broken/detached skeleton. Based on the evaluation and similar reported events, the cause of the broken skeleton is due to excessive stress and force. A review of the scope's records indicate the scope was purchased on (b)(6) 2018 with no repair history. To mitigate the risk of patient injury and device damage the instruction manual it states, ¿do not twist or bend the bending section with your hands. Equipment damage may result; do not insert the insertion tube with excessive force into the ureter or calix. The bending section may be damage.
 
Event Description
The service group was informed that prior to a procedure, the scope was observed to have a broken bending section. There was no patient injury reported as the scope was not used during procedure; no patient contact.
 
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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
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9194641
MDR Text Key219785566
Report Number8010047-2019-03586
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172298
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 10/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2019
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 Manufacturer09/25/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/25/2019
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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