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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, ultrasonic surgical
Product CodeLFL
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
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 1037 1047

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 4209 4358
Failure to Read Input Signal 3253 3253
Detachment of Device or Device Component 2751 2778
Break 1841 1902
Difficult or Delayed Activation 718 718
Material Integrity Problem 663 663
Adverse Event Without Identified Device or Use Problem 544 544
Device Displays Incorrect Message 483 483
Insufficient Information 375 375
Fracture 363 372
Activation, Positioning or Separation Problem 354 354
Device Alarm System 312 312
Failure to Fire 260 260
Activation Problem 255 255
Inappropriate or Unexpected Reset 242 242
Device Fell 217 217
Patient Device Interaction Problem 208 208
Overheating of Device 207 320
Mechanical Problem 206 206
Defective Device 185 185
Output Problem 179 179
Protective Measures Problem 164 164
Noise, Audible 157 157
Intermittent Energy Output 150 150
Peeled/Delaminated 133 133
Delivered as Unsterile Product 131 130
Difficult to Open or Close 112 112
Melted 103 103
Excessive Heating 82 82
Inability to Irrigate 78 228
Appropriate Term/Code Not Available 71 71
Therapeutic or Diagnostic Output Failure 64 64
Failure to Disconnect 61 61
Material Fragmentation 60 60
Failure to Cut 52 52
Incorrect, Inadequate or Imprecise Result or Readings 50 50
Defective Component 50 50
Component Missing 50 50
Crack 47 47
Tear, Rip or Hole in Device Packaging 40 40
No Apparent Adverse Event 35 35
Failure of Device to Self-Test 34 34
Packaging Problem 32 32
Thermal Decomposition of Device 31 31
Failure to Deliver Energy 31 31
Smoking 31 31
Self-Activation or Keying 29 29
Use of Device Problem 29 29
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
Naturally Worn 19 19
Device Damaged Prior to Use 18 18
Temperature Problem 18 18
Material Split, Cut or Torn 18 18
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 Markings/Labelling Problem 12 12
Device Contamination with Chemical or Other Material 12 12
Device Handling Problem 11 11
Unexpected Shutdown 10 10
Device Dislodged or Dislocated 10 10
Vibration 10 10
Product Quality Problem 10 10
Difficult to Remove 9 9
No Device Output 9 9
Electrical /Electronic Property Problem 9 9
Leak/Splash 9 9
Human-Device Interface Problem 9 9
Contamination /Decontamination Problem 9 9
Communication or Transmission Problem 8 8
Ambient Noise Problem 8 8
Failure to Align 8 8
Entrapment of Device 8 8
Display or Visual Feedback Problem 8 8
Disconnection 7 7
Material Rupture 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
Improper or Incorrect Procedure or Method 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11759 11931
No Consequences Or Impact To Patient 4994 5303
Insufficient Information 233 248
No Code Available 219 219
Hemorrhage/Bleeding 201 201
Blood Loss 180 200
No Patient Involvement 138 242
No Known Impact Or Consequence To Patient 138 160
Burn(s) 84 107
Pain 69 69
Fistula 67 67
Injury 67 67
Hematoma 61 61
Unspecified Infection 54 54
Foreign Body In Patient 48 48
Abscess 42 42
Failure to Anastomose 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
No Information 30 30
Obstruction/Occlusion 29 29
Seroma 27 27
Device Embedded In Tissue or Plaque 23 23
Post Operative Wound Infection 23 23
Nerve Damage 21 21
Fever 20 20
Unspecified Tissue Injury 19 19
Not Applicable 17 17
Burn, Thermal 16 16
Superficial (First Degree) Burn 16 21
Inflammation 15 15
Necrosis 15 15
Pleural Effusion 15 15
Paralysis 13 13
Paresis 13 13
Perforation 12 12
Laceration(s) 12 12
Abdominal Pain 12 12
Partial thickness (Second Degree) Burn 11 11
Hernia 11 11
Urinary Retention 10 10
Tissue Damage 10 10
Death 10 10
Pneumothorax 9 9
Sepsis 9 9
Rupture 8 8
Radiation Exposure, Unintended 8 8
Discomfort 8 8
Dysphagia/ Odynophagia 8 8
Anemia 7 7
Pneumonia 7 7
Abdominal Distention 7 7
Speech Disorder 7 7
Thrombosis 7 7
Vomiting 7 7
Impaired Healing 7 7
Unintended Radiation Exposure 7 10
Swelling/ Edema 6 6
Urinary Tract Infection 6 6
Edema 6 6
Bowel Burn 5 5
Wound Dehiscence 5 5
Nausea 5 5
Low Blood Pressure/ Hypotension 5 5
Thyroid Problems 5 5
Hypoesthesia 5 5
Cancer 5 5
Syncope/Fainting 4 4
Full thickness (Third Degree) Burn 4 4
Bowel Perforation 4 4
Peritonitis 4 4
Swelling 4 4
Abnormal Vaginal Discharge 4 4
Perforation of Vessels 4 4
Pyrosis/Heartburn 4 4
Adhesion(s) 4 4
Abrasion 4 4
Unspecified Hepatic or Biliary Problem 4 4
Thrombosis/Thrombus 3 3
Skin Inflammation/ Irritation 3 3
Facial Nerve Paralysis 3 3
Pulmonary Embolism 3 3
Bacterial Infection 3 3
Hemostasis 3 3
Incontinence 3 3
Respiratory Distress 3 3
Spinal Column Injury 3 3
Urinary Frequency 3 3
Weakness 3 3
Lymphoma 3 3
Multiple Organ Failure 2 2
Neuralgia 2 2
Thromboembolism 2 2
Decreased Sensitivity 2 2
Ambulation Difficulties 2 2
Electrolyte Imbalance 2 2
Distress 2 2
Ulcer 2 2
Perforation of Esophagus 2 2
Discharge 2 2
Renal 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
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