CYBER TM 120 PUMS00003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-30 for CYBER TM 120 PUMS00003 manufactured by Quanta System S.p.a..

Event Text Entries

[185936400] The problem is under investigation and could be traced to a component failure. We are unaware about operator injury. We are waiting for additional information from distributor.
Patient Sequence No: 1, Text Type: N, H10


[185936401] The laser system had a failure that did not allow to use it properly. No adverse effects to patient were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004378299-2020-00036
MDR Report Key9897918
Report SourceDISTRIBUTOR
Date Received2020-03-30
Date of Report2020-03-27
Date of Event2020-02-17
Date Mfgr Received2020-02-27
Device Manufacturer Date2010-02-26
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMR. FRANCESCO DELL'ANTONIO
Manufacturer StreetVIA ACQUEDOTTO, 109
Manufacturer CitySAMARATE, VARESE 21017
Manufacturer CountryIT
Manufacturer Postal21017
Manufacturer G1QUANTA SYSTEM S.P.A.
Manufacturer StreetVIA ACQUEDOTTO, 109
Manufacturer CitySAMARATE, 21017
Manufacturer CountryIT
Manufacturer Postal Code21017
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCYBER TM 120
Generic NameSURGICAL LASER
Product CodeGEX
Date Received2020-03-30
Model NumberPUMS00003
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerQUANTA SYSTEM S.P.A.
Manufacturer AddressVIA ACQUEDOTTO, 109 SAMARATE, 21017 IT 21017


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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