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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 5
KATALYST SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MICONVEY TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MISONIX INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TENDONOVA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2934 2988
2021 3288 3333
2022 3422 3470
2023 4215 4245
2024 4017 4063

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 5153 5153
Failure to Read Input Signal 3976 3976
Detachment of Device or Device Component 2754 2754
Break 901 901
Difficult or Delayed Activation 891 891
Material Integrity Problem 792 792
Activation, Positioning or Separation Problem 422 422
Insufficient Information 402 402
Fracture 377 393
Adverse Event Without Identified Device or Use Problem 336 336
Device Alarm System 299 299
Inappropriate or Unexpected Reset 297 297
Failure to Fire 266 266
Activation Problem 244 244
Patient Device Interaction Problem 225 225
Overheating of Device 190 299
Protective Measures Problem 166 166
Delivered as Unsterile Product 158 158
Noise, Audible 140 140
Mechanical Problem 130 130
Peeled/Delaminated 120 120
Device Displays Incorrect Message 113 113
Difficult to Open or Close 110 110
Output Problem 104 104
Excessive Heating 87 87
Inability to Irrigate 78 176
Intermittent Energy Output 77 77
Failure to Disconnect 71 71
Defective Device 68 68
No Apparent Adverse Event 54 54
Appropriate Term/Code Not Available 54 54
Self-Activation or Keying 45 45
Crack 43 43
Tear, Rip or Hole in Device Packaging 41 41
Device Fell 39 39
Degraded 37 37
Failure to Deliver Energy 34 34
Therapeutic or Diagnostic Output Failure 34 34
Melted 34 34
Smoking 32 32
Use of Device Problem 31 31
Failure to Cut 27 27
Manufacturing, Packaging or Shipping Problem 24 24
Failure of Device to Self-Test 22 22
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Naturally Worn 20 20
Suction Problem 20 20
Power Problem 19 19
Connection Problem 18 18
Packaging Problem 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14633 14829
No Consequences Or Impact To Patient 2282 2312
Insufficient Information 268 289
Hemorrhage/Bleeding 207 207
Burn(s) 89 117
No Code Available 83 83
Blood Loss 79 79
No Known Impact Or Consequence To Patient 75 85
No Patient Involvement 66 102
Pain 51 51
Foreign Body In Patient 49 49
Fistula 43 43
Hematoma 41 41
Unspecified Infection 40 40
Injury 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Abscess 32 32
Unspecified Tissue Injury 24 24
Obstruction/Occlusion 24 24
Post Operative Wound Infection 23 23
Failure to Anastomose 22 22
Nerve Damage 19 19
Device Embedded In Tissue or Plaque 18 18
Seroma 17 17
Superficial (First Degree) Burn 16 21
Partial thickness (Second Degree) Burn 15 15
Fever 15 15
Unintended Radiation Exposure 14 17
Abdominal Pain 14 14
Swelling/ Edema 13 13
Laceration(s) 12 12
Paresis 12 12
Pleural Effusion 12 12
Inflammation 11 11
No Information 10 10
Perforation 10 10
Necrosis 9 9
Burn, Thermal 9 9
Death 8 8
Anemia 8 8
Impaired Healing 7 7
Pneumonia 7 7
Urinary Retention 7 7
Rupture 7 7
Pneumothorax 7 7
Hernia 7 7
Vomiting 7 7
Speech Disorder 7 7
Dysphagia/ Odynophagia 6 6
Wound Dehiscence 6 6

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 Olympus Corporation of the Americas II Oct-12-2023
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