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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
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
MDR Year
MDR Reports
MDR Events
2020
238
238
2021
194
194
2022
247
247
2023
390
390
2024
748
748
2025
535
535
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
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