OLYMPUS PK MORCELLATOR WA90200A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-26 for OLYMPUS PK MORCELLATOR WA90200A manufactured by Olympus Corporation Of America.

MAUDE Entry Details

Report NumberMW5088411
MDR Report Key8837581
Date Received2019-07-26
Date of Report2019-07-22
Date of Event2019-06-12
Date Added to Maude2019-07-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameOLYMPUS PK MORCELLATOR
Generic NameELECTROSURGICAL CUTTING & COAGULATION
Product CodeGEI
Date Received2019-07-26
Model NumberWA90200A
Lot NumberU1707046
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS CORPORATION OF AMERICA

Device Sequence Number: 2

Brand NamePNEUMOLINER
Generic NameCONTAINMENT SYSTEM, LAPAROSCOPIC POWER MORCELLATION, WITH INSTRUMENT PORT
Product CodePMU
Date Received2019-07-26
Model NumberWA90500US
Lot Number113202
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerOLYMPUS CORPORATION OF AMERICA


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other 2019-07-26

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