TPLC - Total Product Life Cycle

show TPLC since

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	719	719
Use of Device Problem	357	357
Unintended Deflation	312	312
False Negative Result	201	201
Inappropriate Audible Prompt/Feedback	132	132
Device Sensing Problem	107	107
Break	91	91
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 Sense	44	44
Failure to Power Up	44	44
False Positive Result	42	42
Computer Software Problem	29	29
Noise, Audible	28	28
Application Program Freezes, Becomes Nonfunctional	26	26
Inflation Problem	26	26
Connection Problem	25	25
Gas/Air Leak	25	25
Sensing Intermittently	23	23
Circuit Failure	22	22
Material Puncture/Hole	15	15
Material Protrusion/Extrusion	14	14
Partial Blockage	12	12
Vibration	12	12
Failure to Deflate	11	11
No Apparent Adverse Event	11	11
Signal Artifact/Noise	10	10
Failure to Unfold or Unwrap	10	10
Therapeutic or Diagnostic Output Failure	10	10
Fracture	9	9
Material Too Soft/Flexible	8	8
Intermittent Continuity	8	8
No Device Output	7	7
Intermittent Loss of Power	7	7
Blocked Connection	7	7
Material Twisted/Bent	7	7
Physical Resistance/Sticking	7	7
Problem with Software Installation	6	6
Difficult to Insert	6	6
Insufficient Information	6	6
Deformation Due to Compressive Stress	6	6
Deflation Problem	5	5
Fluid/Blood Leak	5	5
Device Damaged Prior to Use	5	5
Material Deformation	5	5
Display or Visual Feedback Problem	5	5
Defective Device	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	1913	1913
Unintended Extubation	303	303
No Consequences Or Impact To Patient	165	165
Nerve Damage	64	64
Airway Obstruction	51	51
Low Oxygen Saturation	48	48
Insufficient Information	30	30
Paralysis	24	24
Unspecified Tissue Injury	22	22
No Known Impact Or Consequence To Patient	20	20
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
Paresis	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
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