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	1072	1072
Use of Device Problem	364	364
Unintended Deflation	343	343
False Negative Result	232	232
Inappropriate Audible Prompt/Feedback	222	222
Device Sensing Problem	108	108
Break	106	106
Obstruction of Flow	94	94
Leak/Splash	80	80
Unable to Obtain Readings	61	61
Failure to Power Up	58	58
False Positive Result	51	51
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
Inflation Problem	27	27
Connection Problem	27	27
Gas/Air Leak	25	25
Sensing Intermittently	24	24
Material Protrusion/Extrusion	17	17
Material Puncture/Hole	15	15
Signal Artifact/Noise	14	14
Failure to Unfold or Unwrap	13	13
No Apparent Adverse Event	13	13
Vibration	12	12
Partial Blockage	12	12
Therapeutic or Diagnostic Output Failure	12	13
Failure to Deflate	11	11
Material Twisted/Bent	11	11
Fracture	9	9
Material Too Soft/Flexible	9	9
No Device Output	9	9
Insufficient Information	8	8
Device Damaged Prior to Use	8	8
Intermittent Continuity	8	8
Physical Resistance/Sticking	7	7
Problem with Software Installation	7	7
Blocked Connection	7	7
Difficult to Insert	7	7
Deformation Due to Compressive Stress	7	7
Intermittent Loss of Power	7	7
Defective Device	6	6
Material Deformation	6	6
Display or Visual Feedback Problem	6	6
Output Problem	5	5
Deflation Problem	5	5
Fluid/Blood Leak	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2376	2376
Unintended Extubation	407	407
No Consequences Or Impact To Patient	165	165
Nerve Damage	70	70
Low Oxygen Saturation	53	53
Insufficient Information	51	51
Airway Obstruction	51	51
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	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
Paresis	5	5
Pain	5	5
Dyspnea	5	5
Burn(s)	5	5
Obstruction/Occlusion	5	5
Low Blood Pressure/ Hypotension	5	5
Unspecified Infection	5	5
Fatigue	5	5
Cardiac Arrest	4	4
No Patient Involvement	4	4
Pneumothorax	4	4
Laceration(s)	4	4
Scar Tissue	4	4
Cyanosis	3	3
Respiratory Arrest	3	3
Brain Injury	3	3
Injury	3	3
Tachycardia	3	3
Sore Throat	3	3
Speech Disorder	3	3
Decreased Respiratory Rate	2	2
Perforation of Esophagus	2	2
Ischemia	2	2
Fungal Infection	2	2
Paresthesia	2	2
Mediastinal Shift	2	2
Irritation	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