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
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	1101	1101
Use of Device Problem	364	364
Unintended Deflation	352	352
False Negative Result	239	239
Inappropriate Audible Prompt/Feedback	224	224
Device Sensing Problem	108	108
Break	106	106
Obstruction of Flow	95	95
Leak/Splash	80	80
Unable to Obtain Readings	61	61
Failure to Power Up	58	58
False Positive Result	52	52
Adverse Event Without Identified Device or Use Problem	51	51
Failure to Sense	44	44
Circuit Failure	32	32
Application Program Freezes, Becomes Nonfunctional	32	32
Computer Software Problem	31	31
Noise, Audible	28	28
Connection Problem	27	27
Inflation Problem	27	27
Gas/Air Leak	25	25
Sensing Intermittently	24	24
Material Protrusion/Extrusion	17	17
Signal Artifact/Noise	15	15
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
No Device Output	9	9
Material Too Soft/Flexible	9	9
Fracture	9	9
Intermittent Continuity	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
Difficult to Insert	7	7
Physical Resistance/Sticking	7	7
Blocked Connection	7	7
Defective Device	6	6
Display or Visual Feedback Problem	6	6
Material Deformation	6	6
Fluid/Blood Leak	5	5
Deflation Problem	5	5
Output Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2424	2424
Unintended Extubation	410	410
No Consequences Or Impact To Patient	165	165
Nerve Damage	70	70
Insufficient Information	54	54
Low Oxygen Saturation	54	54
Airway Obstruction	52	52
Paralysis	30	30
Unspecified Tissue Injury	22	22
No Known Impact Or Consequence To Patient	20	20
Hypoventilation	15	15
Extubate	13	13
Bronchospasm	10	10
Hemorrhage/Bleeding	10	11
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
Paresis	5	5
Pain	5	5
Dyspnea	5	5
Obstruction/Occlusion	5	5
Low Blood Pressure/ Hypotension	5	5
Burn(s)	5	5
Pneumothorax	4	4
Scar Tissue	4	4
Laceration(s)	4	4
No Patient Involvement	4	4
Cardiac Arrest	4	4
Cyanosis	3	3
Tachycardia	3	3
Speech Disorder	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	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