SONICISION SCD48

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-31 for SONICISION SCD48 manufactured by Covidien Mfg Dc Boulder.

Event Text Entries

[186017069] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186017070] According to the reporter, during a procedure, the device had an activation issue and the tip broke during the procedure. Nothing fell into the patient's cavity. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1717344-2020-00372
MDR Report Key9908806
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-22
Date Mfgr Received2020-03-13
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN MFG DC BOULDER
Manufacturer Street5920 LONGBOW DR
Manufacturer CityBOULDER CO 803013299
Manufacturer CountryUS
Manufacturer Postal Code803013299
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSONICISION
Generic NameINSTRUMENT, ULTRASONIC SURGICAL
Product CodeLFL
Date Received2020-03-31
Model NumberSCD48
Catalog NumberSCD48
Lot Number60320114X
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MFG DC BOULDER
Manufacturer Address5920 LONGBOW DR BOULDER CO 803013299 US 803013299


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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