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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 Device Reprocessing Problem (1091)
Patient Problem Hepatitis (1897)
Event Type  Injury  
Event Description
A study coordinator (physician) reported, after an ureteroscopy using a urf reusable ureteroscope (exact model and serial number not provided).A patient contracted hepatitis b.The physician suggests insufficient sterilization prior to using the reusable ureteroscope as the possible cause.No additional consequences to the patient were reported.It is not known what interventions /treatment the patient received as a result.The patient's current condition is unknown.No further information can be requested.The reported stated they did not want to be contacted.
 
Manufacturer Narrative
Model number: the physician reported urf reusable scope.The exact model and serial number were not provided.Urf-p6r chosen as a representative for the device line.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00361.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the reported issue could not be determined.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 Key13892168
MDR Text Key293152747
Report Number8010047-2022-04965
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170340833
UDI-Public04953170340833
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 Study,Health Professional
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 09/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberURF-P6R
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/03/2022
Initial Date FDA Received03/24/2022
Supplement Dates Manufacturer Received08/16/2022
Supplement Dates FDA Received09/05/2022
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 Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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