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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device instrument, ultrasonic surgical
Product CodeLFL
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 2
ENDOPRIME INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 3
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 3
INTEGRA
  SUBSTANTIALLY EQUIVALENT 6
INTEGRA LIFESCIENCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
KATALYST SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MISONIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SRA DEVELOPMENTS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2776 2776
2016 2686 2686
2017 3266 3266
2018 3460 3460
2019 3153 3153
2020 1940 1940

Device Problems MDRs with this Device Problem Events in those MDRs
Break 6861 6861
Tip 3719 3719
Pad 2088 2088
Device Displays Incorrect Message 1928 1928
Detachment Of Device Component 1580 1580
Knife 1202 1202
Detachment of Device or Device Component 1054 1054
Material Separation 771 771
Component Falling 765 765
Device Operates Differently Than Expected 684 684
Adverse Event Without Identified Device or Use Problem 475 475
Melted 405 405
Device Inoperable 350 350
Noise, Audible 299 299
Device Fell 291 291
Jaw 278 278
Inability to Irrigate 266 266
Defective Device 248 248
Handpiece 242 242
Mechanical Problem 229 229
Fracture 227 227
Overheating of Device 224 224
Probe 209 209
Device Alarm System 196 196
Peeled/Delaminated 189 189
Failure to Cut 167 167
Needle 154 154
Component Missing 143 143
Thermal Decomposition of Device 136 136
Output Problem 134 134
Intermittent Energy Output 125 125
Insufficient Information 121 121
Material Fragmentation 118 118
Failure to Fire 115 115
Crack 110 110
Loose or Intermittent Connection 97 97
Failure of Device to Self-Test 92 92
Device Contamination with Chemical or Other Material 83 83
Device Stops Intermittently 83 83
Defective Component 83 83
Appropriate Term/Code Not Available 83 83
Switch, Push Button 80 80
Difficult to Open or Close 75 75
Self-Activation or Keying 68 68
Loss of Power 59 59
Failure to Power Up 59 59
Activation Problem 58 58
Device Dislodged or Dislocated 56 56
Device Packaging Compromised 56 56
Waveguide 52 52
Material Integrity Problem 51 51
Smoking 51 51
Tear, Rip or Hole in Device Packaging 49 49
Difficult or Delayed Activation 49 49
Therapeutic or Diagnostic Output Failure 48 48
Material Deformation 46 46
Connection Problem 42 42
Mechanical Jam 42 42
Naturally Worn 41 41
Packaging Problem 41 41
Sticking 40 40
Split 38 38
Insulation 36 36
Incorrect, Inadequate or Imprecise Resultor Readings 34 34
Temperature Problem 33 33
Failure to Form Staple 32 32
Failure To Adhere Or Bond 32 32
Use of Device Problem 30 30
Protective Measures Problem 30 30
Device Sensing Problem 29 29
Failure to Read Input Signal 28 28
Difficult to Remove 27 27
Failure to Deliver Energy 27 27
Clamp 26 26
Activation, Positioning or SeparationProblem 26 26
Device Damaged Prior to Use 26 26
Mechanics Altered 26 26
Delivered as Unsterile Product 26 26
Physical Resistance/Sticking 25 25
Disassembly 25 25
Device Slipped 25 25
Knob 24 24
Device Or Device Fragments Location Unknown 23 23
Contamination /Decontamination Problem 21 21
Failure to Sense 19 19
Loss of or Failure to Bond 18 18
Housing 18 18
Leak/Splash 18 18
Disconnection 17 17
Hole In Material 17 17
Failure to Align 17 17
Device Subassembly 16 16
Manufacturing, Packaging or Shipping Problem 15 15
Improper or Incorrect Procedure or Method 15 15
Energy Output Problem 15 15
Positioning Problem 14 14
Power Problem 14 14
Product Quality Problem 13 13
Device Remains Activated 13 13
Inappropriate or Unexpected Reset 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 13814 13814
No Known Impact Or Consequence To Patient 1514 1514
No Code Available 1141 1141
No Patient Involvement 487 487
Foreign body, removal of 364 364
Blood Loss 247 247
No Information 181 181
Injury 81 81
Burn(s) 65 65
Hemorrhage/Bleeding 64 64
Pain 47 47
Foreign Body In Patient 43 43
Not Applicable 43 43
Fistula 41 41
Hematoma 41 41
Unspecified Infection 38 38
Device Embedded In Tissue or Plaque 36 36
Burn, Thermal 35 35
Abscess 29 29
Failure to Anastomose 23 23
Death 21 21
Seroma 20 20
Tissue Damage 16 16
Nerve Damage 15 15
Partial thickness (Second Degree) Burn 15 15
Bleeding 14 14
Obstruction/Occlusion 12 12
Radiation Exposure, Unintended 11 11
Necrosis 11 11
Paralysis 10 10
Inflammation 10 10
Fever 9 9
Discomfort 9 9
Surgical procedure, additional 8 8
Abdominal Pain 7 7
Edema 7 7
Sepsis 7 7
Thrombosis 7 7
Bowel Perforation 7 7
Hernia 7 7
Rupture 6 6
Swelling 6 6
Full thickness (Third Degree) Burn 6 6
Post Operative Wound Infection 5 5
Dysphagia/ Odynophagia 5 5
Abnormal Vaginal Discharge 4 4
Paresis 4 4
Hypoesthesia 4 4
Urinary Retention 4 4
Bruise/Contusion 4 4
Pleural Effusion 4 4
Bacterial Infection 4 4
Nausea 4 4
Laceration(s) 4 4
Liver Damage/Dysfunction 4 4
Pneumothorax 3 3
Respiratory Distress 3 3
Hemostasis 3 3
Vomiting 3 3
Weakness 3 3
Unknown (for use when the patient's condition is not known) 3 3
Complaint, Ill-Defined 3 3
Meningitis 3 3
Hospitalization required 3 3
Surgical procedure 3 3
Other (for use when an appropriate patient code cannot be identified) 3 3
Urinary Frequency 3 3
Neurological Deficit/Dysfunction 3 3
Wound Dehiscence 3 3
Abrasion 3 3
Bowel Burn 2 2
Anemia 2 2
Vessel Or Plaque, Device Embedded In 2 2
Pyrosis/Heartburn 2 2
Ischemia 2 2
Perforation 2 2
Perforation of Vessels 2 2
Exsanguination 2 2
Therapeutic Effects, Unexpected 2 2
Peritonitis 2 2
Discharge 2 2
Decreased Sensitivity 2 2
Cancer 2 2
Lymphoma 2 2
Abdominal Distention 2 2
Ascites 2 2
Electric Shock 2 2
Inadequate Pain Relief 2 2
Transfusion of blood products 2 2
Urinary Tract Infection 2 2
Incontinence 2 2
Adhesion(s) 2 2
Scar Tissue 2 2
Pulmonary Dysfunction 2 2
Pneumonia 2 2
Seizures 1 1
Liver Laceration(s) 1 1
Itching Sensation 1 1
Adult Respiratory Distress Syndrome 1 1
Arrhythmia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon Endo-Surgery Inc II Jun-01-2018
2 Ethicon Endo-Surgery Inc II Nov-16-2015
3 Integra LifeSciences Corp. II Dec-08-2019
4 Integra LifeSciences Corp. II Feb-23-2018
5 Stryker Instruments Div. of Stryker Corporation II Apr-13-2016
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