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	1248	1248
Unintended Deflation	399	399
False Negative Result	265	265
Inappropriate Audible Prompt/Feedback	250	250
Use of Device Problem	220	220
Obstruction of Flow	105	105
Device Sensing Problem	97	97
Break	89	89
Leak/Splash	67	67
Failure to Power Up	59	59
Unable to Obtain Readings	53	53
False Positive Result	52	52
Adverse Event Without Identified Device or Use Problem	41	41
Circuit Failure	39	39
Application Program Freezes, Becomes Nonfunctional	39	39
Computer Software Problem	32	32
Failure to Sense	31	31
Noise, Audible	28	28
Connection Problem	24	24
Gas/Air Leak	24	24
Inflation Problem	21	21
Material Protrusion/Extrusion	17	17
Signal Artifact/Noise	16	16
Sensing Intermittently	14	14
Failure to Unfold or Unwrap	13	13
Partial Blockage	12	12
Material Puncture/Hole	12	12
Vibration	12	12
Failure to Deflate	11	11
No Device Output	10	10
Material Too Soft/Flexible	10	10
Material Twisted/Bent	10	10
No Apparent Adverse Event	9	9
Difficult to Insert	9	9
Therapeutic or Diagnostic Output Failure	9	9
Fracture	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
Material Deformation	7	7
Deflation Problem	6	6
Defective Device	6	6
Insufficient Information	6	6
Blocked Connection	6	6
Physical Resistance/Sticking	5	5
Detachment of Device or Device Component	5	5
Fitting Problem	4	4
Erratic or Intermittent Display	4	4
Intermittent Continuity	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2589	2589
Unintended Extubation	437	437
Insufficient Information	73	73
Nerve Damage	69	69
Low Oxygen Saturation	53	53
Airway Obstruction	53	53
Paralysis	29	29
Unspecified Tissue Injury	22	22
Hypoventilation	16	16
Hemorrhage/Bleeding	11	12
Bronchospasm	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
Fatigue	5	5
Bradycardia	5	5
Paresis	5	5
Obstruction/Occlusion	5	5
Dyspnea	5	5
Unspecified Infection	4	4
Low Blood Pressure/ Hypotension	4	4
Scar Tissue	4	4
Pain	4	4
Cardiac Arrest	4	4
Laceration(s)	4	4
Burn(s)	4	4
Cyanosis	3	3
High Blood Pressure/ Hypertension	3	3
Arrhythmia	3	3
Pneumothorax	3	3
Speech Disorder	3	3
Sore Throat	3	3
Brain Injury	3	3
Respiratory Arrest	3	3
Tachycardia	3	3
Unintended Radiation Exposure	2	2
Decreased Respiratory Rate	2	2
Numbness	2	2
Paresthesia	2	2
Ischemia	2	2
Apnea	2	2
Hypersensitivity/Allergic reaction	2	2
Electric Shock	2	2
Perforation of Esophagus	2	2
Wheezing	2	2
Fungal Infection	2	2
Mediastinal Shift	2	2
Sepsis	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