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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 Problem Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 07/10/2020
Event Type  malfunction  
Manufacturer Narrative
Device was received and evaluated at olympus (b)(4) site. Evaluation determined that the device ¿a- rubber¿ section has a cut with non-standard angle. Bending section was found broken and due to a cut on connecting tube, leak was observed. In addition, the image guide bundle was broken and defective. The adhesive between connecting tube and mouthpiece was found detached. The reported failure was confirmed. Root cause likely attributed to user¿s maintenance and or handling issue.
 
Event Description
It was reported that during device maintenance, damaged on the distal end and infiltration was observed. There was no patient involvement on this event. No user harm was reported.
 
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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 Key10795736
MDR Text Key224630443
Report Number8010047-2020-08583
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K172298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2018
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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