ULTRA PLUME-AWAY 6.0 SMOKE EVACUATION SYSTEM 0620-030-606

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for ULTRA PLUME-AWAY 6.0 SMOKE EVACUATION SYSTEM 0620-030-606 manufactured by Cooper Surgical, Inc..

Event Text Entries

[175667818] Product labeling on the cooper surgical, ultra plume-away 6. 0, smoke evacuation system had been noted to be discolored (yellowish color to portion of label) upon its arrival. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report NumberMW5092298
MDR Report Key9596243
Date Received2020-01-15
Date of Report2020-01-13
Date of Event2020-01-10
Date Added to Maude2020-01-16
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 Report3

Device Sequence Number: 1

Brand NameULTRA PLUME-AWAY 6.0 SMOKE EVACUATION SYSTEM
Generic NameTUBE, SMOKE REMOVAL, ENDOSCOPIC
Product CodeFCZ
Date Received2020-01-15
Model Number0620-030-606
Catalog Number0620-030-606
Lot Number269501
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCOOPER SURGICAL, INC.
Manufacturer AddressTRUMBULL CT 06611 US 06611

Device Sequence Number: 2

Brand NameULTRA PLUME-AWAY 6.0 SMOKE EVACUATION SYSTEM
Generic NameTUBE, SMOKE REMOVAL, ENDOSCOPIC
Product CodeFCZ
Date Received2020-01-15
Model Number0620-030-606
Catalog Number0620-030-606
Lot Number269767
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerCOOPER SURGICAL, INC.
Manufacturer AddressTRUMBULL CT 06611 US 06611

Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-15
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