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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 LIFE SCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
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
SHANGHAI SAINTS SAGES SURGICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMTP TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SRA DEVELOPMENTS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
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 3289 3340
2022 3422 3472
2023 4215 4245
2024 4017 4063
2025 3576 3635

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 6146 6146
Failure to Read Input Signal 4886 4886
Detachment of Device or Device Component 3090 3090
Difficult or Delayed Activation 1187 1187
Break 953 954
Material Integrity Problem 917 917
Activation, Positioning or Separation Problem 519 519
Insufficient Information 465 465
Fracture 457 490
Inappropriate or Unexpected Reset 427 427
Adverse Event Without Identified Device or Use Problem 399 399
Patient Device Interaction Problem 378 378
Failure to Fire 302 302
Device Alarm System 299 299
Peeled/Delaminated 269 269
Activation Problem 268 268
Overheating of Device 243 374
Delivered as Unsterile Product 197 197
Protective Measures Problem 186 186
Noise, Audible 163 163
Mechanical Problem 137 137
Difficult to Open or Close 124 124
Device Displays Incorrect Message 115 120
Output Problem 105 105
Excessive Heating 94 94
Inability to Irrigate 91 210
Failure to Disconnect 89 89
Intermittent Energy Output 81 81
Self-Activation or Keying 77 77
Defective Device 77 77
No Apparent Adverse Event 66 66
Crack 64 64
Degraded 62 62
Appropriate Term/Code Not Available 59 59
Failure to Deliver Energy 47 47
Naturally Worn 44 44
Tear, Rip or Hole in Device Packaging 43 43
Therapeutic or Diagnostic Output Failure 40 45
Device Fell 39 39
Melted 38 38
Smoking 38 38
Use of Device Problem 34 34
Material Fragmentation 33 33
Failure to Cut 33 33
Manufacturing, Packaging or Shipping Problem 28 28
Failure of Device to Self-Test 22 26
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Device Remains Activated 21 21
Energy Output Problem 21 21
Connection Problem 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17959 18213
No Consequences Or Impact To Patient 2282 2312
Insufficient Information 365 415
Hemorrhage/Bleeding 298 298
Burn(s) 104 145
No Code Available 83 83
Blood Loss 79 79
No Known Impact Or Consequence To Patient 75 85
No Patient Involvement 66 102
Pain 64 64
Foreign Body In Patient 63 63
Unspecified Infection 60 60
Hematoma 59 59
Fistula 55 55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 44 44
Abscess 42 42
Seroma 41 41
Injury 39 39
Failure to Anastomose 36 36
Unspecified Tissue Injury 36 36
Obstruction/Occlusion 33 33
Post Operative Wound Infection 32 32
Nerve Damage 29 29
Fever 21 21
Unintended Radiation Exposure 20 23
Superficial (First Degree) Burn 19 24
Device Embedded In Tissue or Plaque 18 18
Pleural Effusion 17 17
Perforation 17 17
Paresis 15 15
Swelling/ Edema 15 15
Partial thickness (Second Degree) Burn 15 15
Inflammation 14 14
Abdominal Pain 14 14
Laceration(s) 13 13
Necrosis 11 11
Anemia 11 11
Hernia 10 10
No Information 10 10
Speech Disorder 10 10
Urinary Retention 9 9
Paralysis 9 9
Pneumothorax 9 9
Rupture 9 9
Tissue Breakdown 9 9
Burn, Thermal 9 9
Nausea 9 9
Dysphagia/ Odynophagia 9 9
Impaired Healing 8 8
Death 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 Olympus Corporation of the Americas II Jan-21-2025
6 Olympus Corporation of the Americas II Oct-12-2023
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