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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, nerve
Regulation Description Surgical nerve stimulator/locator.
Product CodeETN
Regulation Number 874.1820
Device Class 2


Premarket Reviews
ManufacturerDecision
AD-TECH
  SUBSTANTIALLY EQUIVALENT 1
AD-TECH MEDICAL INSTRUMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INOMED MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 145 145
2017 117 117
2018 250 250
2019 314 314
2020 238 238
2021 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 370 370
Failure to Sense 138 138
Device Operates Differently Than Expected 99 99
Device Sensing Problem 80 80
Adverse Event Without Identified Device or Use Problem 58 58
Unable to Obtain Readings 48 48
False Negative Result 46 46
Break 42 42
Noise, Audible 38 38
Sensing Intermittently 34 34
Leak/Splash 31 31
Inflation Problem 25 25
Air Leak 22 22
Material Puncture/Hole 18 18
Device Stops Intermittently 15 15
Occlusion Within Device 14 14
Connection Problem 14 14
Partial Blockage 13 13
Intermittent Continuity 13 13
Appropriate Term/Code Not Available 12 12
Obstruction of Flow 11 11
Deflation Problem 11 11
Gas Leak 8 8
Electrical /Electronic Property Problem 7 7
Failure to Read Input Signal 7 7
Fracture 6 6
False Positive Result 6 6
Deformation Due to Compressive Stress 5 5
Difficult to Remove 5 5
Failure to Power Up 5 5
No Apparent Adverse Event 5 5
Loose or Intermittent Connection 5 5
Device Displays Incorrect Message 4 4
Material Deformation 4 4
Audible Prompt/Feedback Problem 4 4
Insufficient Information 4 4
Therapeutic or Diagnostic Output Failure 4 4
Defective Device 4 4
No Device Output 3 3
Material Separation 3 3
Fluid Leak 3 3
Display or Visual Feedback Problem 3 3
Failure to Deliver Energy 3 3
Material Fragmentation 3 3
Hole In Material 3 3
Mechanical Problem 3 3
Signal Artifact/Noise 3 3
Intermittent Loss of Power 3 3
Material Protrusion/Extrusion 3 3
Device Inoperable 3 3
Defective Component 3 3
Fitting Problem 3 3
Failure to Transmit Record 2 2
Device Alarm System 2 2
Decrease in Pressure 2 2
Detachment Of Device Component 2 2
Physical Resistance/Sticking 2 2
Positioning Problem 2 2
Electrical Shorting 2 2
Impedance Problem 2 2
Failure to Fire 2 2
Tear, Rip or Hole in Device Packaging 2 2
Self-Activation or Keying 2 2
Material Twisted/Bent 2 2
Mechanical Jam 2 2
Detachment of Device or Device Component 2 2
Output Problem 2 2
Material Too Soft/Flexible 2 2
Material Split, Cut or Torn 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
No Display/Image 2 2
Communication or Transmission Problem 2 2
Computer Operating System Problem 1 1
Device Dislodged or Dislocated 1 1
Folded 1 1
Patient-Device Incompatibility 1 1
Blocked Connection 1 1
Unsealed Device Packaging 1 1
Loss of Power 1 1
Loss of or Failure to Bond 1 1
No Audible Alarm 1 1
Degraded 1 1
Failure to Discharge 1 1
Burst Container or Vessel 1 1
Complete Blockage 1 1
Migration or Expulsion of Device 1 1
Infusion or Flow Problem 1 1
Installation-Related Problem 1 1
No Flow 1 1
Device-Device Incompatibility 1 1
Failure to Advance 1 1
Low Battery 1 1
Compatibility Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Distortion 1 1
Optical Problem 1 1
Pressure Problem 1 1
Scratched Material 1 1
Migration 1 1
Complete Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 628 628
No Known Impact Or Consequence To Patient 217 217
No Clinical Signs, Symptoms or Conditions 97 97
Extubate 82 82
No Patient Involvement 35 35
Nerve Damage 25 25
Airway Obstruction 21 21
Low Oxygen Saturation 17 17
Paralysis 13 13
Facial Nerve Paralysis 13 13
Injury 12 12
Unintended Extubation 11 11
Paresis 8 8
No Information 5 5
Respiratory Distress 4 4
Obstruction/Occlusion 4 4
Edema 4 4
Bronchospasm 4 4
Dyspnea 4 4
Burn(s) 3 3
Occlusion 3 3
Bradycardia 3 3
Hypoxia 3 3
Unspecified Tissue Injury 3 3
No Code Available 2 2
Nervous System Injury 2 2
Radiation Exposure, Unintended 2 2
Bacterial Infection 2 2
Post Operative Wound Infection 2 2
Sore Throat 2 2
Tissue Damage 2 2
Dysphasia 2 2
Oversedation 2 2
Irritation 2 2
Low Blood Pressure/ Hypotension 2 2
Insufficient Information 2 2
Sedation 2 2
Partial thickness (Second Degree) Burn 1 1
Respiratory Acidosis 1 1
Skin Tears 1 1
Decreased Sensitivity 1 1
Fluid Discharge 1 1
Hypoventilation 1 1
Dysphagia/ Odynophagia 1 1
Memory Loss/Impairment 1 1
Neurological Deficit/Dysfunction 1 1
Increased Sensitivity 1 1
Swelling 1 1
Therapeutic Effects, Unexpected 1 1
Ulceration 1 1
Mediastinal Shift 1 1
Coma 1 1
Rupture 1 1
Blinking, Excessive 1 1
Therapeutic Response, Decreased 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Urinary Retention 1 1
Twitching 1 1
Dizziness 1 1
Laceration(s) of Esophagus 1 1
Seizures 1 1
Needle Stick/Puncture 1 1
Abnormal Blood Gases 1 1
Apnea 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Hemostasis 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Nausea 1 1
Pneumothorax 1 1
Local Reaction 1 1
Pain 1 1
Device Embedded In Tissue or Plaque 1 1
Full thickness (Third Degree) Burn 1 1
Missing Value Reason 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Xomed, Inc. II Dec-23-2016
2 Neurovision Medical Products Inc II Aug-27-2020
3 Stryker Instruments Div. of Stryker Corporation II Oct-01-2019
4 The Magstim Company Limited II Jan-15-2021
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