TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
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

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