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
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	1314	1314
Unintended Deflation	444	444
False Negative Result	283	283
Inappropriate Audible Prompt/Feedback	262	262
Use of Device Problem	222	222
Obstruction of Flow	115	115
Device Sensing Problem	97	97
Break	92	92
Leak/Splash	67	67
Failure to Power Up	58	58
False Positive Result	52	52
Unable to Obtain Readings	50	50
Circuit Failure	41	41
Adverse Event Without Identified Device or Use Problem	41	41
Application Program Freezes or Fails to Launch	40	40
Computer Software Problem	34	34
Failure to Sense	30	30
Noise, Audible	28	28
Connection Problem	23	23
Inflation Problem	22	22
Material Protrusion/Extrusion	20	20
Signal Artifact/Noise	17	17
Gas/Air Leak	17	17
Sensing Intermittently	14	14
Failure to Unfold or Unwrap	13	13
Partial Blockage	12	12
Vibration	12	12
Failure to Deflate	11	11
Fracture	11	11
Material Twisted/Bent	11	11
No Apparent Adverse Event	10	10
Detachment of Device or Device Component	10	10
Material Puncture/Hole	10	10
Material Too Soft/Flexible	10	10
No Device Output	9	9
Difficult to Insert	9	9
Device Damaged Prior to Use	8	8
Problem with Software Installation	7	7
Deformation Due to Compressive Stress	7	7
Material Deformation	7	7
Intermittent Loss of Power	6	6
Insufficient Device Problem Information	6	6
Blocked Connection	6	6
Deflation Problem	5	5
Device Misassembled During Manufacturing /Shipping	5	5
Component Missing	5	5
Physical Resistance/Sticking	5	5
Erratic or Intermittent Display	4	4
Fitting Problem	4	4
Intermittent Continuity	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2739	2739
Unintended Extubation	463	463
Insufficient Information	78	78
Nerve Damage	69	69
Airway Obstruction	54	54
Low Oxygen Saturation	53	53
Paralysis	29	29
Unspecified Tissue Injury	22	22
Hypoventilation	16	16
Foreign Body In Patient	12	12
Bronchospasm	11	11
Hemorrhage/Blood Loss/Bleeding	11	12
Unspecified Respiratory Problem	9	9
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	8	8
Facial Paralysis	7	7
Hypoxia	7	7
Swelling/ Edema	7	7
Bradycardia	5	5
Paresis	5	5
Dyspnea	5	5
Obstruction/Occlusion	5	5
Fatigue	5	5
Scar Tissue	4	4
Pain	4	4
Laceration(s)	4	4
Low Blood Pressure/ Hypotension	4	4
Unspecified Infection	4	4
Cardiac Arrest	4	4
Burn(s)	4	4
Sore Throat	3	3
Arrhythmia	3	3
Tachycardia	3	3
Pneumothorax	3	3
Speech Disorder	3	3
Brain Injury	3	3
High Blood Pressure/ Hypertension	3	3
Cyanosis	3	3
Respiratory Arrest	3	3
Wheezing	3	3
Unintended Radiation Exposure	2	2
Unspecified Nervous System Problem	2	2
Paresthesia	2	2
Mediastinal Shift	2	2
Upper Respiratory Tract Injury	2	2
Sepsis	2	2
Numbness	2	2
Decreased Respiratory Rate	2	2
Fungal Infection	2	2
Ischemia	2	2
Electric Shock	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	Spes Medica	II	Jun-25-2021
8	Technomed Europe	II	Sep-12-2024
9	The Magstim Company Limited	II	Jan-15-2021