PLASMA LOOP WA22706S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-31 for PLASMA LOOP WA22706S manufactured by Olympus Corporation.

MAUDE Entry Details

Report NumberMW5090816
MDR Report Key9266146
Date Received2019-10-31
Date of Report2019-10-29
Date of Event2019-10-28
Date Added to Maude2019-11-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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 NamePLASMA LOOP
Generic NameELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Product CodeFAS
Date Received2019-10-31
Returned To Mfg2019-10-29
Catalog NumberWA22706S
Lot Number1000040033
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS CORPORATION
Manufacturer AddressHAMBURG DE US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-31

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