SONICISION CORDLESS ULTRASONIC DISSECTOR SCD396

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for SONICISION CORDLESS ULTRASONIC DISSECTOR SCD396 manufactured by Covidien.

Event Text Entries

[185013903] During surgical procedure when surgeon attempted to use device, and per rn, "had no charge to it".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9882563
MDR Report Key9882563
Date Received2020-03-26
Date of Report2020-03-13
Date of Event2020-03-12
Report Date2020-03-13
Date Reported to FDA2020-03-13
Date Reported to Mfgr2020-03-26
Date Added to Maude2020-03-26
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSONICISION CORDLESS ULTRASONIC DISSECTOR
Generic NameINSTRUMENT, ULTRASONIC SURGICAL
Product CodeLFL
Date Received2020-03-26
Model NumberSCD396
Catalog NumberSCD396
Lot Number93520122X
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address5920 LONGBOW DRIVE BOULDER CO 80301 US 80301


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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