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TPLC
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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
2
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
MDR Year
MDR Reports
MDR Events
2020
238
238
2021
194
194
2022
247
247
2023
390
390
2024
748
748
2025
396
396
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
651
651
Use of Device Problem
356
356
Unintended Deflation
278
278
False Negative Result
184
184
Inappropriate Audible Prompt/Feedback
118
118
Device Sensing Problem
107
107
Obstruction of Flow
84
84
Break
82
82
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
42
42
False Positive Result
40
40
Noise, Audible
28
28
Computer Software Problem
27
27
Inflation Problem
26
26
Connection Problem
25
25
Application Program Freezes, Becomes Nonfunctional
25
25
Gas/Air Leak
24
24
Sensing Intermittently
23
23
Circuit Failure
18
18
Material Puncture/Hole
15
15
Material Protrusion/Extrusion
13
13
Partial Blockage
12
12
Vibration
12
12
No Apparent Adverse Event
11
11
Therapeutic or Diagnostic Output Failure
10
10
Failure to Deflate
10
10
Signal Artifact/Noise
9
9
Fracture
9
9
Intermittent Continuity
8
8
Material Too Soft/Flexible
8
8
No Device Output
7
7
Failure to Unfold or Unwrap
7
7
Intermittent Loss of Power
7
7
Blocked Connection
7
7
Insufficient Information
6
6
Deformation Due to Compressive Stress
6
6
Problem with Software Installation
6
6
Material Deformation
5
5
Device Damaged Prior to Use
5
5
Difficult to Insert
5
5
Display or Visual Feedback Problem
5
5
Deflation Problem
5
5
Defective Device
5
5
Fluid/Blood Leak
5
5
Material Split, Cut or Torn
4
4
Output Problem
4
4
Material Twisted/Bent
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1793
1793
Unintended Extubation
291
291
No Consequences Or Impact To Patient
165
165
Nerve Damage
64
64
Airway Obstruction
49
49
Low Oxygen Saturation
46
46
Insufficient Information
23
23
Unspecified Tissue Injury
22
22
No Known Impact Or Consequence To Patient
20
20
Paralysis
19
19
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
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
Paresis
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
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