BERKELEY? VC?-10 VACUUM CURETTAGE SYSTEM (115V) VC-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-20 for BERKELEY? VC?-10 VACUUM CURETTAGE SYSTEM (115V) VC-10 manufactured by Gyrus Acmi, Inc..

Event Text Entries

[70317486]
Patient Sequence No: 1, Text Type: N, H10


[70317487] Suction device stopped suctioning. Staff noted a burning smell. They immediately replaced suction unit with another device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6416726
MDR Report Key6416726
Date Received2017-03-20
Date of Report2017-03-16
Date of Event2017-02-17
Report Date2017-03-14
Date Reported to FDA2017-03-14
Date Reported to Mfgr2017-03-14
Date Added to Maude2017-03-20
Event Key0
Report Source CodeUser Facility 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 Details

Brand NameBERKELEY? VC?-10 VACUUM CURETTAGE SYSTEM (115V)
Generic NameSYSTEM, VACUUM
Product CodeHHK
Date Received2017-03-20
Model NumberVC-10
Device AvailabilityY
Device Age7 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGYRUS ACMI, INC.
Manufacturer Address93 NORTH PLEASANT ST. NORWALK OH 44857 US 44857


Patients

Patient NumberTreatmentOutcomeDate
10 2017-03-20

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