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TPLC
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Device
instrument, ultrasonic surgical
Product Code
LFL
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
COVIDIEN, LLC
SUBSTANTIALLY EQUIVALENT
3
ETHICON ENDO-SURGERY, LLC
SUBSTANTIALLY EQUIVALENT
3
INTEGRA LIFESCIENCES CORPORATION
SUBSTANTIALLY EQUIVALENT
5
KATALYST SURGICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDISONIC TECHNOLOGY CO
SUBSTANTIALLY EQUIVALENT
1
MICONVEY TECHNOLOGIES CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MISONIX INC.
SUBSTANTIALLY EQUIVALENT
2
MISONIX, INC.
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS MEDICAL SYSTEMS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SMTP TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
SMTP TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SRA DEVELOPMENTS LTD
SUBSTANTIALLY EQUIVALENT
1
STRYKER CORPORATION
SUBSTANTIALLY EQUIVALENT
3
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
TENDONOVA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
TENEX HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
3461
3461
2019
3153
3445
2020
2934
2988
2021
3288
3333
2022
3422
3470
2023
627
633
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3048
3109
Material Separation
2943
3092
Detachment of Device or Device Component
2273
2300
Failure to Read Input Signal
1988
1988
Device Displays Incorrect Message
946
946
Adverse Event Without Identified Device or Use Problem
535
535
Difficult or Delayed Activation
443
443
Material Integrity Problem
416
416
Device Alarm System
317
317
Insufficient Information
297
297
Device Fell
295
295
Fracture
289
289
Detachment Of Device Component
266
266
Defective Device
248
248
Failure to Fire
247
247
Mechanical Problem
237
237
Melted
234
234
Activation, Positioning or Separation Problem
202
202
Overheating of Device
200
303
Activation Problem
198
198
Peeled/Delaminated
184
184
Noise, Audible
181
181
Output Problem
181
181
Intermittent Energy Output
159
159
Patient Device Interaction Problem
153
153
Inability to Irrigate
148
283
Inappropriate or Unexpected Reset
134
134
Device Operates Differently Than Expected
122
122
Difficult to Open or Close
119
119
Protective Measures Problem
113
113
Delivered as Unsterile Product
108
107
Appropriate Term/Code Not Available
104
104
Material Fragmentation
99
99
Component Falling
96
96
Failure to Cut
83
83
Component Missing
79
79
Thermal Decomposition of Device
73
73
Excessive Heating
73
73
Device Inoperable
68
68
Defective Component
64
64
Therapeutic or Diagnostic Output Failure
62
62
Failure of Device to Self-Test
56
56
Crack
52
52
Tear, Rip or Hole in Device Packaging
48
48
Incorrect, Inadequate or Imprecise Result or Readings
47
47
Device Stops Intermittently
44
44
Failure to Disconnect
40
40
Loose or Intermittent Connection
40
40
Use of Device Problem
38
38
Naturally Worn
38
38
Smoking
36
36
Packaging Problem
35
35
Connection Problem
34
34
Failure to Deliver Energy
32
32
Self-Activation or Keying
27
27
Material Deformation
27
27
Device Contamination with Chemical or Other Material
27
27
No Apparent Adverse Event
27
27
Physical Resistance/Sticking
27
27
Manufacturing, Packaging or Shipping Problem
25
25
Device Sensing Problem
25
25
Failure to Form Staple
25
25
Loss of Power
25
25
Degraded
23
23
Device Damaged Prior to Use
22
22
Contamination /Decontamination Problem
20
20
Difficult to Remove
20
20
Material Split, Cut or Torn
20
20
Temperature Problem
20
20
Suction Problem
19
19
Energy Output Problem
18
18
Product Quality Problem
15
15
Device Dislodged or Dislocated
15
15
Material Twisted/Bent
15
15
Device Remains Activated
14
14
Failure to Power Up
13
13
Activation Failure
13
13
Device Handling Problem
12
12
Human-Device Interface Problem
12
12
Leak/Splash
12
12
No Device Output
12
12
Failure to Sense
11
11
Vibration
11
11
Power Problem
11
11
Unexpected Shutdown
10
10
Failure to Align
10
10
Entrapment of Device
10
10
Display or Visual Feedback Problem
10
10
Electrical /Electronic Property Problem
10
10
Device Difficult to Setup or Prepare
9
9
Split
9
9
Ambient Noise Problem
8
8
Device Packaging Compromised
8
8
Material Frayed
8
8
Mechanical Jam
8
8
Device Emits Odor
7
7
Intermittent Continuity
7
7
Material Rupture
7
7
Improper or Incorrect Procedure or Method
7
7
Device Markings/Labelling Problem
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
8072
8381
No Clinical Signs, Symptoms or Conditions
7312
7450
No Patient Involvement
264
368
No Code Available
260
260
No Known Impact Or Consequence To Patient
233
255
Blood Loss
222
242
Insufficient Information
175
189
Hemorrhage/Bleeding
168
168
Injury
82
82
Burn(s)
77
96
No Information
70
70
Pain
67
67
Fistula
62
62
Hematoma
56
56
Foreign Body In Patient
52
52
Unspecified Infection
50
50
Abscess
36
36
Failure to Anastomose
31
31
Seroma
28
28
Not Applicable
28
28
Burn, Thermal
23
23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
23
23
Post Operative Wound Infection
22
22
Obstruction/Occlusion
21
21
Nerve Damage
20
20
Fever
20
20
Device Embedded In Tissue or Plaque
19
19
Pleural Effusion
15
15
Inflammation
15
15
Necrosis
15
15
Death
14
14
Partial thickness (Second Degree) Burn
13
13
Tissue Damage
12
12
Paralysis
12
12
Unspecified Tissue Injury
12
12
Paresis
11
11
Urinary Retention
11
11
Hernia
11
11
Radiation Exposure, Unintended
11
11
Sepsis
10
10
Pneumothorax
9
9
Abdominal Pain
9
9
Rupture
9
9
Discomfort
8
8
Thrombosis
7
7
Abdominal Distention
7
7
Bowel Perforation
7
7
Wound Dehiscence
7
7
Edema
7
7
Dysphagia/ Odynophagia
6
6
Perforation
6
6
Pneumonia
6
6
Speech Disorder
6
6
Impaired Healing
6
6
Unintended Radiation Exposure
6
6
Hypoesthesia
5
5
Thyroid Problems
5
5
Urinary Tract Infection
5
5
Perforation of Vessels
5
5
Cancer
5
5
Full thickness (Third Degree) Burn
5
5
Superficial (First Degree) Burn
5
8
Nausea
5
5
Anemia
5
5
Adhesion(s)
4
4
Abrasion
4
4
Bowel Burn
4
4
Liver Damage/Dysfunction
4
4
Hemostasis
4
4
Vomiting
4
4
Abnormal Vaginal Discharge
4
4
Swelling
4
4
Peritonitis
4
4
Unspecified Hepatic or Biliary Problem
4
4
Swelling/ Edema
3
3
Spinal Column Injury
3
3
Urinary Frequency
3
3
Weakness
3
3
Ascites
3
3
Incontinence
3
3
Respiratory Distress
3
3
Facial Nerve Paralysis
3
3
Pulmonary Embolism
3
3
Abortion
2
2
Arrhythmia
2
2
Aspiration/Inhalation
2
2
Cardiac Arrest
2
2
Cellulitis
2
2
Pyrosis/Heartburn
2
2
Exsanguination
2
2
Pulmonary Dysfunction
2
2
Renal Failure
2
2
Neurological Deficit/Dysfunction
2
2
Laceration(s)
2
2
Low Blood Pressure/ Hypotension
2
2
Ischemia
2
2
Respiratory Failure
2
2
Decreased Sensitivity
2
2
Thromboembolism
2
2
Lymphoma
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien Llc
II
Dec-03-2021
2
Covidien Llc
II
Aug-10-2021
3
Ethicon Endo-Surgery Inc
II
Aug-26-2021
4
Ethicon Endo-Surgery Inc
II
Jun-01-2018
5
Integra LifeSciences Corp.
II
Dec-08-2019
6
Integra LifeSciences Corp.
II
Feb-23-2018
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