BIPOLAR WORKING ELEMENT ONLY W/ SPRING 27040EB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-26 for BIPOLAR WORKING ELEMENT ONLY W/ SPRING 27040EB manufactured by Karl Storz Se & Co. Kg.

MAUDE Entry Details

Report Number9610617-2019-00084
MDR Report Key9122747
Report SourceUSER FACILITY
Date Received2019-09-26
Date of Report2019-09-24
Date of Event2019-08-29
Date Mfgr Received2019-08-29
Device Manufacturer Date2015-04-01
Date Added to Maude2019-09-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. SUSIE CHEN
Manufacturer Street2151 E. GRAND AVENUE
Manufacturer CityEL SEGUNDO CA 90245
Manufacturer CountryUS
Manufacturer Postal90245
Manufacturer Phone4242188201
Manufacturer G1KARL STORZ SE & CO.KG
Manufacturer StreetDR.-KARL-STORZ -STRASSE 34 78532
Manufacturer CityTUTTLINGEN, GM,
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIPOLAR WORKING ELEMENT ONLY W/ SPRING
Generic NameBI-POLAR RESECTOSCOPE
Product CodeFAS
Date Received2019-09-26
Returned To Mfg2019-09-23
Model Number27040EB
Catalog Number27040EB
Lot NumberRU05
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerKARL STORZ SE & CO. KG
Manufacturer AddressDR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM,


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-09-26

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