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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
ALLOTROPE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
BIOSYS BIYOMEDIKAL MUHENDISLIK SAN. VE TIC. A.S.
  SUBSTANTIALLY EQUIVALENT 1
CHECKPOINT SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
INOMED MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RETROPSOAS TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU HAISHEN MEDICAL DEVICE ASSOCIATES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 238 238
2021 194 194
2022 247 247
2023 390 390
2024 748 748
2025 396 396

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 651 651
Use of Device Problem 356 356
Unintended Deflation 278 278
False Negative Result 184 184
Inappropriate Audible Prompt/Feedback 118 118
Device Sensing Problem 107 107
Obstruction of Flow 84 84
Break 82 82
Leak/Splash 80 80
Unable to Obtain Readings 61 61
Adverse Event Without Identified Device or Use Problem 50 50
Failure to Sense 44 44
Failure to Power Up 42 42
False Positive Result 40 40
Noise, Audible 28 28
Computer Software Problem 27 27
Inflation Problem 26 26
Connection Problem 25 25
Application Program Freezes, Becomes Nonfunctional 25 25
Gas/Air Leak 24 24
Sensing Intermittently 23 23
Circuit Failure 18 18
Material Puncture/Hole 15 15
Material Protrusion/Extrusion 13 13
Partial Blockage 12 12
Vibration 12 12
No Apparent Adverse Event 11 11
Therapeutic or Diagnostic Output Failure 10 10
Failure to Deflate 10 10
Signal Artifact/Noise 9 9
Fracture 9 9
Intermittent Continuity 8 8
Material Too Soft/Flexible 8 8
No Device Output 7 7
Failure to Unfold or Unwrap 7 7
Intermittent Loss of Power 7 7
Blocked Connection 7 7
Insufficient Information 6 6
Deformation Due to Compressive Stress 6 6
Problem with Software Installation 6 6
Material Deformation 5 5
Device Damaged Prior to Use 5 5
Difficult to Insert 5 5
Display or Visual Feedback Problem 5 5
Deflation Problem 5 5
Defective Device 5 5
Fluid/Blood Leak 5 5
Material Split, Cut or Torn 4 4
Output Problem 4 4
Material Twisted/Bent 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1793 1793
Unintended Extubation 291 291
No Consequences Or Impact To Patient 165 165
Nerve Damage 64 64
Airway Obstruction 49 49
Low Oxygen Saturation 46 46
Insufficient Information 23 23
Unspecified Tissue Injury 22 22
No Known Impact Or Consequence To Patient 20 20
Paralysis 19 19
Hypoventilation 14 14
Extubate 13 13
Bronchospasm 10 10
Hemorrhage/Bleeding 10 10
Foreign Body In Patient 10 10
Unspecified Respiratory Problem 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Hypoxia 7 7
Swelling/ Edema 7 7
Bradycardia 6 6
Unspecified Infection 5 5
Fatigue 5 5
Pain 5 5
Dyspnea 5 5
Low Blood Pressure/ Hypotension 5 5
Obstruction/Occlusion 5 5
Burn(s) 5 5
Pneumothorax 4 4
Scar Tissue 4 4
Laceration(s) 4 4
Cardiac Arrest 4 4
No Patient Involvement 4 4
Cyanosis 3 3
Tachycardia 3 3
Speech Disorder 3 3
Paresis 3 3
Brain Injury 3 3
Respiratory Arrest 3 3
Sore Throat 3 3
Injury 3 3
Irritation 2 2
Paresthesia 2 2
Ischemia 2 2
Perforation of Esophagus 2 2
Decreased Respiratory Rate 2 2
Fungal Infection 2 2
Mediastinal Shift 2 2
Sepsis 2 2
Hypersensitivity/Allergic reaction 2 2
Arrhythmia 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Checkpoint Surgical Inc II Mar-26-2025
2 Medtronic Xomed, Inc. II Jan-10-2024
3 Medtronic Xomed, Inc. I Sep-01-2022
4 Medtronic Xomed, Inc. II Mar-10-2022
5 Neurovision Medical Products Inc II Aug-23-2024
6 Neurovision Medical Products Inc II Aug-27-2020
7 Spes Medica II Jun-25-2021
8 Technomed Europe II Sep-12-2024
9 The Magstim Company Limited II Jan-15-2021
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