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
EPINEURON TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
INOMED MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	3
MEDTRONIC XOMED, INC.
	SUBSTANTIALLY EQUIVALENT	4
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	1248	1248
Unintended Deflation	399	399
Use of Device Problem	366	366
False Negative Result	265	265
Inappropriate Audible Prompt/Feedback	250	250
Break	112	112
Device Sensing Problem	108	108
Obstruction of Flow	105	105
Leak/Splash	80	80
Unable to Obtain Readings	63	63
Failure to Power Up	59	59
False Positive Result	53	53
Adverse Event Without Identified Device or Use Problem	52	52
Failure to Sense	44	44
Application Program Freezes, Becomes Nonfunctional	39	39
Circuit Failure	39	39
Computer Software Problem	32	32
Connection Problem	30	30
Noise, Audible	28	28
Inflation Problem	27	27
Gas/Air Leak	25	25
Sensing Intermittently	24	24
Signal Artifact/Noise	17	17
Material Protrusion/Extrusion	17	17
Material Puncture/Hole	15	15
Failure to Unfold or Unwrap	13	13
No Apparent Adverse Event	13	13
Partial Blockage	12	12
Vibration	12	12
Therapeutic or Diagnostic Output Failure	12	13
Failure to Deflate	11	11
Material Twisted/Bent	11	11
Material Too Soft/Flexible	10	10
Fracture	10	10
No Device Output	10	10
Difficult to Insert	9	9
Intermittent Continuity	8	8
Material Deformation	8	8
Insufficient Information	8	8
Device Damaged Prior to Use	8	8
Problem with Software Installation	7	7
Intermittent Loss of Power	7	7
Deformation Due to Compressive Stress	7	7
Defective Device	7	7
Physical Resistance/Sticking	7	7
Blocked Connection	7	7
Deflation Problem	6	6
Display or Visual Feedback Problem	6	6
Fluid/Blood Leak	5	5
Detachment of Device or Device Component	5	5

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