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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation. The evaluation found that the bending section tube was fractured and dented. Additionally, the device channel tube leaked. The faulty parts need replacement to meet olympus functional standard. The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time. However, if additional information becomes available this report will be supplemented accordingly.
 
Event Description
A user facility reported to olympus that, the uretero-reno videoscope bending section was defective. The procedure was completed with a similar device. Upon inspection and testing of the returned device, it was observed that the bending manipulation section and insertion tube was defective. The bending rubber was broken with metal sticking out of the device. This report is being submitted for the event found during evaluation. There was no harm or user injury reported due to the event.
 
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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 Key13290305
MDR Text Key284032136
Report Number8010047-2022-01642
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170343582
UDI-Public04953170343582
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/19/2022 Patient Sequence Number: 1
Treatment
CLV-S190 UNKNOWN SERIAL AND LOT NUMBER
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