SONICISION SCD396

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 SCD396 manufactured by Covidien Mfg Dc Boulder.

Event Text Entries

[186018063] Evaluation summary: one device was returned for evaluation. The returned product did not meet specification as received. Visual inspection of the disposable device revealed that the tip of the waveguide was broken off. The broken piece was not returned. The reported condition was not confirmed because the device needs to be in an activated state to develop fractures. The device stopped working. Investigation personnel performed functional testing on the returned hand piece using a test lab generator and battery. The assembled device returned a green light and a welcome tone, but immediately returned a red light emitting diode (led) indicator with an error tone (alarm activation) when the device was activated. This characteristic indicated that the device was not functional. The waveguide had its tip missing. Investigation personnel concluded that the titanium waveguide was in use when it cracked and broke off, and may have come in contact with any of the following; hemostats, clips, staples, retractors, etc. During use. The investigation identified the cause of the reported event to be user error. The device instructions for use currently contain a warning against contact between the dissector tip and metal objects (hemostats, clips, staples, retractors, etc. ) during activation. Contact with metal objects during use will cause the active blade to crack and may eventually break off. This issue is specific to ultrasonic dissectors. The instructions for use (ifu) advises device users to visually inspect all system components for breaks, cracks, nicks, or other damages prior to use. Ifu also states: do not use damaged components. Use of damaged components may result in injury to the patient or user. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186018064] According to the reporter, prior to use, the device broke. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1717344-2020-00368
MDR Report Key9908610
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-16
Date Mfgr Received2020-03-13
Device Manufacturer Date2017-10-13
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
Returned To Mfg2020-03-12
Model NumberSCD396
Catalog NumberSCD396
Lot Number72860021X
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
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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