Harmonic ACE HARH36

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-13 for Harmonic ACE HARH36 manufactured by Stryker Sustainability.

Event Text Entries

[144812272] During a laparoscopic appendectomy, the reprocessed harmonic scalpel did not work/cut and had to be replaced. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number8603183
MDR Report Key8603183
Date Received2019-05-13
Date of Report2019-04-23
Date of Event2019-01-04
Report Date2019-05-03
Date Reported to FDA2019-05-03
Date Reported to Mfgr2019-05-13
Date Added to Maude2019-05-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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 Sequence Number: 0

Brand NameHarmonic ACE
Generic NameINSTRUMENT, ULTRASONIC SURGICAL
Product CodeNLQ
Date Received2019-05-13
Model NumberHARH36
Catalog NumberHARH36
Lot Number8871391
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerSTRYKER SUSTAINABILITY
Manufacturer Address1810 W. DRAKE DR. TEMPE AZ 85283 US 85283

Device Sequence Number: 1

Brand NameHarmonic ACE
Generic NameINSTRUMENT, ULTRASONIC SURGICAL
Product CodeLFL
Date Received2019-05-13
Model NumberHARH36
Catalog NumberHARH36
Lot Number8871391
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER SUSTAINABILITY
Manufacturer Address1810 W. DRAKE DR. TEMPE AZ 85283 US 85283

Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-13
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