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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-P7
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
During inspection and testing, service found the bending section cover and insertion tube were damaged.The bending section cover was perforated by broken metal wires protruding from the inside of the insertion section.In addition, the scope was not water-tight due to perforation of the bending section cover, angulation was insufficient due to elongation of the angle wire, the image guide bundle was significantly broken due to external factors, specified resolution could not be obtained due to damage to the objective lens, a stain was observed in the image due to damage to the image guide bundle, the angle lever was cracked due to external factors, and there were scratches on multiple parts of the device.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
An olympus employee reported a pinhole in the bending section cover of the scope.The subject device was sent to an olympus service center for evaluation.During inspection and testing, service found the insertion tube was damaged and metal wires were protruding.This report is being submitted for the malfunction found during evaluation (protruding metal wires).There was no harm or user injury reported due to the event.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to a strong twisting operation to the left and right when the bending section is fixed and an irregular load such as a sudden angle operation.It is recommended that the user facility inspect the device prior to use and on a regular basis continuously.Olympus will continue to monitor field performance for this device.
 
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Brand Name
URETERO-RENO FIBERSCOPE
Type of Device
URETERO-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 Key14278253
MDR Text Key299586505
Report Number8010047-2022-07503
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170403811
UDI-Public04953170403811
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberURF-P7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2022
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/04/2022
Initial Date FDA Received05/04/2022
Supplement Dates Manufacturer Received07/06/2022
Supplement Dates FDA Received08/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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