Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS STRYKER HARMONIC HD 1000I; INSTRUMENT, ULTRASONIC SURGICAL, REPROCESSED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER SUSTAINABILITY SOLUTIONS STRYKER HARMONIC HD 1000I; INSTRUMENT, ULTRASONIC SURGICAL, REPROCESSED Back to Search Results
Model Number HARMONIC HD 1000
Device Problems Intermittent Continuity (1121); Loss of Power (1475); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2019
Event Type  malfunction  
Event Description
The device worked in the previous case but in this case it would give an alert that says "advanced features are not available in this device"; then it would say "recognizing device" and work for a couple seconds then default again.It was hooked up in the hall with trimedx and it would recognize the device and ask you to activate, but wouldn't let you activate it.The device would go back to recognizing.The device kept jumping around.We took it apart and tried again.It powered off when we plugged it back in.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STRYKER HARMONIC HD 1000I
Type of Device
INSTRUMENT, ULTRASONIC SURGICAL, REPROCESSED
Manufacturer (Section D)
STRYKER SUSTAINABILITY SOLUTIONS
1810 w. drake dr.
tempe AZ 85283
MDR Report Key8607300
MDR Text Key144957830
Report Number8607300
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberHARMONIC HD 1000
Device Lot Number46150483
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/01/2019
Event Location Hospital
Date Report to Manufacturer05/14/2019
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Age14235 DA
-
-