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	3
MEDTRONIC XOMED, INC.
	SUBSTANTIALLY EQUIVALENT	3
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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	757	757
Use of Device Problem	358	358
Unintended Deflation	320	320
False Negative Result	209	209
Inappropriate Audible Prompt/Feedback	136	136
Device Sensing Problem	107	107
Break	93	93
Obstruction of Flow	86	86
Leak/Splash	80	80
Unable to Obtain Readings	61	61
Adverse Event Without Identified Device or Use Problem	50	50
Failure to Power Up	49	49
Failure to Sense	44	44
False Positive Result	42	42
Computer Software Problem	31	31
Noise, Audible	28	28
Application Program Freezes, Becomes Nonfunctional	28	28
Inflation Problem	27	27
Circuit Failure	26	26
Connection Problem	25	25
Gas/Air Leak	25	25
Sensing Intermittently	23	23
Material Protrusion/Extrusion	16	16
Material Puncture/Hole	15	15
Failure to Unfold or Unwrap	12	12
Partial Blockage	12	12
Vibration	12	12
Signal Artifact/Noise	11	11
Failure to Deflate	11	11
No Apparent Adverse Event	11	11
Therapeutic or Diagnostic Output Failure	10	10
Fracture	9	9
No Device Output	8	8
Material Too Soft/Flexible	8	8
Intermittent Continuity	8	8
Intermittent Loss of Power	7	7
Blocked Connection	7	7
Material Twisted/Bent	7	7
Problem with Software Installation	7	7
Physical Resistance/Sticking	7	7
Difficult to Insert	6	6
Deformation Due to Compressive Stress	6	6
Insufficient Information	6	6
Material Deformation	6	6
Deflation Problem	5	5
Fluid/Blood Leak	5	5
Defective Device	5	5
Device Damaged Prior to Use	5	5
Display or Visual Feedback Problem	5	5
Erratic or Intermittent Display	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1969	1969
Unintended Extubation	307	307
No Consequences Or Impact To Patient	165	165
Nerve Damage	64	64
Airway Obstruction	51	51
Low Oxygen Saturation	48	48
Insufficient Information	35	35
Paralysis	25	25
Unspecified Tissue Injury	22	22
No Known Impact Or Consequence To Patient	20	20
Hypoventilation	14	14
Extubate	13	13
Bronchospasm	10	10
Foreign Body In Patient	10	10
Hemorrhage/Bleeding	10	10
Unspecified Respiratory Problem	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Swelling/ Edema	7	7
Hypoxia	7	7
Bradycardia	6	6
Unspecified Infection	5	5
Paresis	5	5
Dyspnea	5	5
Pain	5	5
Fatigue	5	5
Low Blood Pressure/ Hypotension	5	5
Burn(s)	5	5
Obstruction/Occlusion	5	5
Pneumothorax	4	4
Laceration(s)	4	4
No Patient Involvement	4	4
Scar Tissue	4	4
Cardiac Arrest	4	4
Sore Throat	3	3
Injury	3	3
Brain Injury	3	3
Respiratory Arrest	3	3
Speech Disorder	3	3
Cyanosis	3	3
Tachycardia	3	3
Paresthesia	2	2
Ischemia	2	2
Irritation	2	2
Perforation of Esophagus	2	2
Decreased Respiratory Rate	2	2
Fungal Infection	2	2
Mediastinal Shift	2	2
Sepsis	2	2
Apnea	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	Jul-09-2025
6	Neurovision Medical Products Inc	II	Aug-23-2024
7	Neurovision Medical Products Inc	II	Aug-27-2020
8	Spes Medica	II	Jun-25-2021
9	Technomed Europe	II	Sep-12-2024
10	The Magstim Company Limited	II	Jan-15-2021