CYSTO-NEPHRO VIDEOSCOPE CYF-VHR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for CYSTO-NEPHRO VIDEOSCOPE CYF-VHR manufactured by Olympus Medical Systems Corp..

MAUDE Entry Details

Report Number2951238-2019-01133
MDR Report Key9146213
Date Received2019-10-02
Date of Report2019-10-02
Date of Event2019-09-04
Date Facility Aware2019-09-04
Report Date2019-09-04
Date Reported to Mfgr2019-09-04
Date Added to Maude2019-10-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCYSTO-NEPHRO VIDEOSCOPE
Generic NameCYSTO-NEPHRO VIDEOSCOPE
Product CodeFAJ
Date Received2019-10-02
Returned To Mfg2019-09-11
Model NumberCYF-VHR
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO 192-8507 JA 192-8507


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.