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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-P6
Device Problems Break (1069); Crack (1135); Peeled/Delaminated (1454); Material Perforation (2205)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/19/2017
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus medical systems corp. , but was returned to olympus (b)(4). (b)(4) confirmed the reported device damage. (b)(4) found that the bending section of the subject device was cracked at the insertion tube side, an inner part of the bending section was protruding partially from the bending rubber and the adhesive of the bending rubber was chipped. There was a hole in the bending rubber of the subject device and the subject device failed the water leakage test. The manufacturing record of the subject device was reviewed with no irregularity related to the phenomenon. The exact cause of the event could not be concluded at this moment. If additional and significant information becomes available, this report will be supplemented.
 
Event Description
Olympus was informed that the bending function of the subject device did not work properly during an ureteroscopy from the user facility. There was no report of patient injury associated with this event.
 
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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
hiroki moriyama
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
8142642517
MDR Report Key6331019
MDR Text Key67602177
Report Number8010047-2017-00171
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
PK912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Remedial Action Notification
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2017
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
Removal/Correction Number2429304-12/12/2016-042C

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