{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-13"
  },
  "results": [
    {
      "term": "Self-Activation or Keying",
      "count": 184
    },
    {
      "term": "Adverse Event Without Identified Device or Use Problem",
      "count": 148
    },
    {
      "term": "Connection Problem",
      "count": 71
    },
    {
      "term": "Energy Output Problem",
      "count": 54
    },
    {
      "term": "Insufficient Device Problem Information",
      "count": 53
    },
    {
      "term": "Device Remains Activated",
      "count": 52
    },
    {
      "term": "Device Operates Differently Than Expected",
      "count": 48
    },
    {
      "term": "Fire",
      "count": 44
    },
    {
      "term": "Device Displays Incorrect Message",
      "count": 41
    },
    {
      "term": "Inaccurate Delivery",
      "count": 34
    },
    {
      "term": "Break",
      "count": 20
    },
    {
      "term": "Improper or Incorrect Procedure or Method",
      "count": 18
    },
    {
      "term": "Failure to Calibrate",
      "count": 16
    },
    {
      "term": "Device Alarm System",
      "count": 15
    },
    {
      "term": "Sparking",
      "count": 14
    },
    {
      "term": "Arcing",
      "count": 11
    },
    {
      "term": "Electrical Shorting",
      "count": 10
    },
    {
      "term": "Failure to Deliver Energy",
      "count": 10
    },
    {
      "term": "Failure to Obtain Sample",
      "count": 10
    },
    {
      "term": "Image Display Error/Artifact",
      "count": 9
    },
    {
      "term": "Flare or Flash",
      "count": 8
    },
    {
      "term": "Material Integrity Problem",
      "count": 8
    },
    {
      "term": "Noise, Audible",
      "count": 8
    },
    {
      "term": "Overheating of Device",
      "count": 8
    },
    {
      "term": "Smoking",
      "count": 8
    },
    {
      "term": "Unintended Power Up",
      "count": 8
    },
    {
      "term": "Device Inoperable",
      "count": 7
    },
    {
      "term": "Failure to Align",
      "count": 7
    },
    {
      "term": "Loss of Power",
      "count": 7
    },
    {
      "term": "No Apparent Adverse Event",
      "count": 7
    },
    {
      "term": "Appropriate Device Problem Term/Code Not Available",
      "count": 6
    },
    {
      "term": "Failure to Shut Off",
      "count": 6
    },
    {
      "term": "Intermittent Energy Output",
      "count": 6
    },
    {
      "term": "Mechanical Problem",
      "count": 6
    },
    {
      "term": "Melted",
      "count": 6
    },
    {
      "term": "Replace",
      "count": 6
    },
    {
      "term": "Thermal Decomposition of Device",
      "count": 6
    },
    {
      "term": "Computer Software Problem",
      "count": 5
    },
    {
      "term": "Inappropriate/Inadequate Shock/Stimulation",
      "count": 5
    },
    {
      "term": "Device Emits Odor",
      "count": 4
    },
    {
      "term": "Device Stops Intermittently",
      "count": 4
    },
    {
      "term": "Electrical /Electronic Property Problem",
      "count": 4
    },
    {
      "term": "Unknown (for use when the device problem is not known)",
      "count": 4
    },
    {
      "term": "Defective Alarm",
      "count": 3
    },
    {
      "term": "Difficult or Delayed Activation",
      "count": 3
    },
    {
      "term": "Energy Output To Patient Tissue Incorrect",
      "count": 3
    },
    {
      "term": "Loose or Intermittent Connection",
      "count": 3
    },
    {
      "term": "Communication or Transmission Problem",
      "count": 2
    },
    {
      "term": "Component Falling",
      "count": 2
    },
    {
      "term": "Defective Device",
      "count": 2
    },
    {
      "term": "Detachment Of Device Component",
      "count": 2
    },
    {
      "term": "Failure to Cut",
      "count": 2
    },
    {
      "term": "Failure to Form Staple",
      "count": 2
    },
    {
      "term": "Failure to Power Up",
      "count": 2
    },
    {
      "term": "Failure, intermittent",
      "count": 2
    },
    {
      "term": "Hole In Material",
      "count": 2
    },
    {
      "term": "Leak/Splash",
      "count": 2
    },
    {
      "term": "Material Deformation",
      "count": 2
    },
    {
      "term": "Material Separation",
      "count": 2
    },
    {
      "term": "Misassembly During Maintenance/Repair",
      "count": 2
    },
    {
      "term": "No Device Output",
      "count": 2
    },
    {
      "term": "No Display/Image",
      "count": 2
    },
    {
      "term": "Noise",
      "count": 2
    },
    {
      "term": "Output Problem",
      "count": 2
    },
    {
      "term": "Output, low",
      "count": 2
    },
    {
      "term": "Power Problem",
      "count": 2
    },
    {
      "term": "Sticking",
      "count": 2
    },
    {
      "term": "Temperature Problem",
      "count": 2
    },
    {
      "term": "Alarm, audible",
      "count": 1
    },
    {
      "term": "Application Program Problem",
      "count": 1
    },
    {
      "term": "Calibration Error",
      "count": 1
    },
    {
      "term": "Calibration Problem",
      "count": 1
    },
    {
      "term": "Component Missing",
      "count": 1
    },
    {
      "term": "Component or Accessory Incompatibility",
      "count": 1
    },
    {
      "term": "Defective Component",
      "count": 1
    },
    {
      "term": "Device Issue",
      "count": 1
    },
    {
      "term": "Device, removal of (non-implant)",
      "count": 1
    },
    {
      "term": "Difficult to Open or Close",
      "count": 1
    },
    {
      "term": "Difficult to Remove",
      "count": 1
    },
    {
      "term": "Electromagnetic Compatibility Problem",
      "count": 1
    },
    {
      "term": "Electronic Property Issue",
      "count": 1
    },
    {
      "term": "Failure to Auto Stop",
      "count": 1
    },
    {
      "term": "Failure to Fire",
      "count": 1
    },
    {
      "term": "Failure to Sense",
      "count": 1
    },
    {
      "term": "Fluid/Blood Leak",
      "count": 1
    },
    {
      "term": "Grounding Malfunction",
      "count": 1
    },
    {
      "term": "Human-Device Interface Problem",
      "count": 1
    },
    {
      "term": "Infusion or Flow Problem",
      "count": 1
    },
    {
      "term": "Loose",
      "count": 1
    },
    {
      "term": "Loss of or Failure to Bond",
      "count": 1
    },
    {
      "term": "Low Audible Alarm",
      "count": 1
    },
    {
      "term": "Material Fragmentation",
      "count": 1
    },
    {
      "term": "Misfire",
      "count": 1
    },
    {
      "term": "No Audible Prompt/Feedback",
      "count": 1
    },
    {
      "term": "Out-Of-Box Failure",
      "count": 1
    },
    {
      "term": "Output above Specifications",
      "count": 1
    },
    {
      "term": "Output, high",
      "count": 1
    },
    {
      "term": "Positioning Problem",
      "count": 1
    },
    {
      "term": "Reset Problem",
      "count": 1
    },
    {
      "term": "Seal, defective",
      "count": 1
    }
  ]
}