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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
HUNAN HANDLIKE MINIMALLY INVASIVE SURGERY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
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 2690 2725

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 4758 4907
Failure to Read Input Signal 3691 3691
Detachment of Device or Device Component 3009 3036
Break 1871 1932
Difficult or Delayed Activation 811 811
Material Integrity Problem 741 741
Adverse Event Without Identified Device or Use Problem 559 559
Device Displays Incorrect Message 483 483
Insufficient Information 402 402
Activation, Positioning or Separation Problem 399 399
Fracture 395 408
Device Alarm System 312 312
Failure to Fire 284 284
Activation Problem 271 271
Inappropriate or Unexpected Reset 270 270
Overheating of Device 224 354
Patient Device Interaction Problem 219 219
Device Fell 219 219
Mechanical Problem 211 211
Defective Device 185 185
Output Problem 179 179
Protective Measures Problem 173 173
Noise, Audible 171 171
Intermittent Energy Output 151 151
Delivered as Unsterile Product 143 142
Peeled/Delaminated 142 142
Difficult to Open or Close 119 119
Melted 105 105
Excessive Heating 87 87
Inability to Irrigate 83 237
Appropriate Term/Code Not Available 71 71
Failure to Disconnect 66 66
Therapeutic or Diagnostic Output Failure 64 64
Material Fragmentation 60 60
Failure to Cut 55 55
Component Missing 51 51
Crack 50 50
Incorrect, Inadequate or Imprecise Result or Readings 50 50
Defective Component 50 50
Tear, Rip or Hole in Device Packaging 48 48
Self-Activation or Keying 43 43
No Apparent Adverse Event 39 39
Smoking 39 39
Failure to Deliver Energy 34 34
Failure of Device to Self-Test 34 34
Degraded 32 32
Thermal Decomposition of Device 32 32
Packaging Problem 32 32
Use of Device Problem 31 31
Manufacturing, Packaging or Shipping Problem 28 28

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13363 13560
No Consequences Or Impact To Patient 4994 5303
Insufficient Information 250 269
No Code Available 219 219
Hemorrhage/Bleeding 213 213
Blood Loss 180 200
No Patient Involvement 138 242
No Known Impact Or Consequence To Patient 138 160
Burn(s) 94 122
Pain 73 73
Injury 67 67
Fistula 67 67
Hematoma 62 62
Unspecified Infection 57 57
Foreign Body In Patient 51 51
Abscess 43 43
Failure to Anastomose 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
No Information 30 30
Obstruction/Occlusion 29 29
Seroma 27 27
Nerve Damage 26 26
Post Operative Wound Infection 24 24
Device Embedded In Tissue or Plaque 23 23
Unspecified Tissue Injury 21 21
Fever 20 20
Not Applicable 17 17
Partial thickness (Second Degree) Burn 17 17
Superficial (First Degree) Burn 16 21
Burn, Thermal 16 16
Necrosis 16 16
Pleural Effusion 15 15
Inflammation 15 15
Paresis 13 13
Paralysis 13 13
Abdominal Pain 12 12
Laceration(s) 12 12
Perforation 12 12
Hernia 11 11
Urinary Retention 10 10
Death 10 10
Swelling/ Edema 10 10
Tissue Damage 10 10
Pneumothorax 9 9
Anemia 9 9
Sepsis 9 9
Unintended Radiation Exposure 8 11
Discomfort 8 8
Rupture 8 8
Dysphagia/ Odynophagia 8 8

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 Jun-21-2024
5 Integra LifeSciences Corp. II Dec-08-2019
6 Olympus Corporation of the Americas II Oct-12-2023
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