COMPACT CYSTOSCOPE, 7?, 7.9 FR. X 160 MM, 4.2 FR. CHANNEL, ANGLED OCULAR A37026A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-06 for COMPACT CYSTOSCOPE, 7?, 7.9 FR. X 160 MM, 4.2 FR. CHANNEL, ANGLED OCULAR A37026A manufactured by Olympus Winter & Ibe Gmbh.

MAUDE Entry Details

Report Number9610773-2020-00082
MDR Report Key9801674
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-06
Date of Report2020-03-06
Date Mfgr Received2020-02-12
Date Added to Maude2020-03-06
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
Manufacturer ContactMR. DANIEL WLADOW
Manufacturer StreetKUEHNSTRASSE 61
Manufacturer CityHAMBURG 22045
Manufacturer CountryGM
Manufacturer Postal22045
Manufacturer Phone4940669662
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPACT CYSTOSCOPE, 7?, 7.9 FR. X 160 MM, 4.2 FR. CHANNEL, ANGLED OCULAR
Generic NameCOMPACT CYSTOSCOPE
Product CodeGCP
Date Received2020-03-06
Returned To Mfg2020-02-10
Model NumberA37026A
Catalog NumberA37026A
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG 22045 GM 22045


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-06

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