Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
instrument, ultrasonic surgical
Product Code
LFL
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
COVIDIEN, LLC
SUBSTANTIALLY EQUIVALENT
2
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
MISONIX, LLC, A BIOVENTUS COMPANY
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
MDR Year
MDR Reports
MDR Events
2019
3153
3445
2020
2934
2988
2021
3288
3333
2022
3422
3470
2023
4215
4245
2024
742
752
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Separation
4118
4267
Failure to Read Input Signal
3184
3184
Detachment of Device or Device Component
2706
2733
Break
1834
1895
Difficult or Delayed Activation
699
699
Material Integrity Problem
640
640
Adverse Event Without Identified Device or Use Problem
541
541
Device Displays Incorrect Message
483
483
Insufficient Information
370
370
Fracture
357
366
Activation, Positioning or Separation Problem
340
340
Device Alarm System
312
312
Failure to Fire
257
257
Activation Problem
252
252
Inappropriate or Unexpected Reset
235
235
Device Fell
217
217
Mechanical Problem
206
206
Overheating of Device
206
319
Patient Device Interaction Problem
205
205
Defective Device
184
184
Output Problem
179
179
Protective Measures Problem
164
164
Noise, Audible
157
157
Intermittent Energy Output
150
150
Peeled/Delaminated
131
131
Delivered as Unsterile Product
128
127
Difficult to Open or Close
110
110
Melted
102
102
Excessive Heating
82
82
Inability to Irrigate
78
228
Appropriate Term/Code Not Available
71
71
Therapeutic or Diagnostic Output Failure
64
64
Material Fragmentation
60
60
Failure to Disconnect
59
59
Failure to Cut
52
52
Defective Component
50
50
Component Missing
50
50
Incorrect, Inadequate or Imprecise Result or Readings
50
50
Crack
46
46
Tear, Rip or Hole in Device Packaging
40
40
Failure of Device to Self-Test
34
34
No Apparent Adverse Event
34
34
Packaging Problem
32
32
Thermal Decomposition of Device
31
31
Failure to Deliver Energy
31
31
Smoking
31
31
Use of Device Problem
29
29
Self-Activation or Keying
28
28
Manufacturing, Packaging or Shipping Problem
27
27
Degraded
26
26
Loose or Intermittent Connection
25
25
Material Deformation
24
24
Physical Resistance/Sticking
24
24
Power Problem
22
22
Connection Problem
22
22
Suction Problem
22
22
Device Damaged Prior to Use
18
18
Naturally Worn
18
18
Temperature Problem
18
18
Material Split, Cut or Torn
17
17
Material Twisted/Bent
17
17
Energy Output Problem
17
17
Activation Failure
16
16
Failure to Form Staple
15
15
Loss of Power
14
14
Device Remains Activated
13
13
Device Sensing Problem
13
13
Device Contamination with Chemical or Other Material
12
12
Device Markings/Labelling Problem
12
12
Device Handling Problem
11
11
Unexpected Shutdown
10
10
Device Dislodged or Dislocated
10
10
Product Quality Problem
10
10
Vibration
10
10
Difficult to Remove
9
9
No Device Output
9
9
Leak/Splash
9
9
Human-Device Interface Problem
9
9
Contamination /Decontamination Problem
9
9
Ambient Noise Problem
8
8
Failure to Align
8
8
Entrapment of Device
8
8
Display or Visual Feedback Problem
8
8
Electrical /Electronic Property Problem
7
7
Disconnection
7
7
Material Rupture
7
7
Communication or Transmission Problem
7
7
Separation Problem
7
7
Failure to Sense
6
6
Unsealed Device Packaging
6
6
Device Difficult to Setup or Prepare
6
6
Intermittent Continuity
6
6
Fluid/Blood Leak
5
5
Computer Operating System Problem
5
5
Infusion or Flow Problem
5
5
Firing Problem
5
5
Suction Failure
4
4
Mechanical Jam
4
4
Positioning Problem
4
4
Device Emits Odor
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
11473
11645
No Consequences Or Impact To Patient
4994
5303
Insufficient Information
228
243
No Code Available
219
219
Hemorrhage/Bleeding
199
199
Blood Loss
180
200
No Patient Involvement
138
242
No Known Impact Or Consequence To Patient
138
160
Burn(s)
83
106
Pain
68
68
Fistula
67
67
Injury
67
67
Hematoma
61
61
Unspecified Infection
53
53
Foreign Body In Patient
47
47
Abscess
42
42
Failure to Anastomose
33
33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
31
31
No Information
30
30
Obstruction/Occlusion
29
29
Seroma
26
26
Post Operative Wound Infection
23
23
Device Embedded In Tissue or Plaque
21
21
Nerve Damage
21
21
Fever
20
20
Unspecified Tissue Injury
19
19
Not Applicable
17
17
Superficial (First Degree) Burn
16
21
Burn, Thermal
16
16
Inflammation
15
15
Necrosis
15
15
Pleural Effusion
15
15
Paresis
13
13
Perforation
12
12
Paralysis
12
12
Laceration(s)
12
12
Abdominal Pain
12
12
Partial thickness (Second Degree) Burn
11
11
Hernia
10
10
Tissue Damage
10
10
Urinary Retention
10
10
Death
10
10
Sepsis
9
9
Pneumothorax
9
9
Dysphagia/ Odynophagia
8
8
Rupture
8
8
Discomfort
8
8
Radiation Exposure, Unintended
8
8
Speech Disorder
7
7
Abdominal Distention
7
7
Thrombosis
7
7
Anemia
7
7
Pneumonia
7
7
Unintended Radiation Exposure
7
10
Swelling/ Edema
6
6
Edema
6
6
Urinary Tract Infection
6
6
Vomiting
6
6
Impaired Healing
6
6
Hypoesthesia
5
5
Thyroid Problems
5
5
Cancer
5
5
Bowel Burn
5
5
Wound Dehiscence
5
5
Nausea
5
5
Low Blood Pressure/ Hypotension
5
5
Pyrosis/Heartburn
4
4
Abrasion
4
4
Syncope/Fainting
4
4
Unspecified Hepatic or Biliary Problem
4
4
Bowel Perforation
4
4
Full thickness (Third Degree) Burn
4
4
Swelling
4
4
Abnormal Vaginal Discharge
4
4
Perforation of Vessels
4
4
Peritonitis
4
4
Urinary Frequency
3
3
Weakness
3
3
Lymphoma
3
3
Facial Nerve Paralysis
3
3
Pulmonary Embolism
3
3
Adhesion(s)
3
3
Bacterial Infection
3
3
Hemostasis
3
3
Incontinence
3
3
Respiratory Distress
3
3
Spinal Column Injury
3
3
Thrombosis/Thrombus
3
3
Skin Inflammation/ Irritation
3
3
Easy Bruising
2
2
Renal Failure
2
2
Neurological Deficit/Dysfunction
2
2
Liver Damage/Dysfunction
2
2
Ischemia
2
2
Aspiration/Inhalation
2
2
Abortion
2
2
Erythema
2
2
Cardiac Arrest
2
2
Cellulitis
2
2
Multiple Organ Failure
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
Integra LifeSciences Corp.
II
Dec-08-2019
5
Olympus Corporation of the Americas
II
Oct-12-2023
-
-