HARMONIC HARHD36

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for HARMONIC HARHD36 manufactured by Ethicon Endo-surgery, Llc.

Event Text Entries

[185521334] Harmonic handpiece 1000i shears would not make a seal. Pad on harmonic started to peal off handpiece. Switched to reprocessed harmonic.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9896919
MDR Report Key9896919
Date Received2020-03-30
Date of Report2020-03-12
Date of Event2020-02-26
Report Date2020-03-12
Date Reported to FDA2020-03-12
Date Reported to Mfgr2020-03-30
Date Added to Maude2020-03-30
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 OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHARMONIC
Generic NameINSTRUMENT, ULTRASONIC SURGICAL
Product CodeLFL
Date Received2020-03-30
Model NumberHARHD36
Catalog NumberHARHD36
Lot NumberP91J0P
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerETHICON ENDO-SURGERY, LLC
Manufacturer Address475 CALLE C GUAYNABO PR 00969 US 00969


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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