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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 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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