FDA Adverse Event Malfunction Summary report: N

HARMONIC ACE

MDR report key: 3203845 · Received June 21, 2013

Report

Report Number
3203845
Event Type
Malfunction
Date Received
June 21, 2013
Date of Event
June 19, 2013
Report Date
June 21, 2013
Manufacturer
STRYKER SUSTAINABILITY SOLUTIONS
Product Code
LFL
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
RISK MANAGER

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
282618 HARMONIC ACE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER SUSTAINABILITY SOLUTIONS ACE36E 2514481

Patients

Seq Age Sex Outcome Treatment
1 30 YR