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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 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 2
HUNAN HANDLIKE MINIMALLY INVASIVE SURGERY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
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
2021 3289 3340
2022 3422 3472
2023 4215 4245
2024 4017 4063
2025 3907 3965
2026 1248 1276

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 5693 5693
Failure to Read Input Signal 5159 5159
Detachment of Device or Device Component 2995 2995
Difficult or Delayed Activation 1280 1280
Material Integrity Problem 906 906
Break 571 572
Activation, Positioning or Separation Problem 542 542
Inappropriate or Unexpected Reset 444 444
Fracture 442 480
Insufficient Information 435 448
Patient Device Interaction Problem 366 366
Peeled/Delaminated 362 362
Adverse Event Without Identified Device or Use Problem 290 303
Failure to Fire 279 279
Overheating of Device 230 349
Activation Problem 213 213
Delivered as Unsterile Product 201 201
Protective Measures Problem 181 181
Noise, Audible 151 151
Difficult to Open or Close 102 102
Self-Activation or Keying 89 89
Inability to Irrigate 85 171
Failure to Disconnect 85 85
Degraded 81 81
Excessive Heating 79 79
Mechanical Problem 71 71
Material Fragmentation 69 69
No Apparent Adverse Event 66 66
Crack 59 59
Naturally Worn 57 57
Output Problem 56 56
Intermittent Energy Output 45 45
Melted 41 41
Tear, Rip or Hole in Device Packaging 40 40
Failure to Deliver Energy 33 33
Smoking 32 32
Defective Device 31 31
Failure to Cut 30 30
Appropriate Term/Code Not Available 26 26
Therapeutic or Diagnostic Output Failure 26 31
Use of Device Problem 25 25
Material Split, Cut or Torn 22 22
Manufacturing, Packaging or Shipping Problem 21 21
Energy Output Problem 19 19
Temperature Problem 19 19
Power Problem 18 18
Incorrect, Inadequate or Imprecise Result or Readings 17 17
Connection Problem 16 16
Device Remains Activated 16 16
Device Difficult to Setup or Prepare 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19064 19305
Insufficient Information 374 423
Hemorrhage/Bleeding 291 291
Burn(s) 103 143
Foreign Body In Patient 74 74
Pain 51 61
Unspecified Infection 47 47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 43 43
No Consequences Or Impact To Patient 40 40
Unspecified Tissue Injury 40 40
Hematoma 40 40
Seroma 39 39
Fistula 38 38
Failure to Anastomose 35 35
Post Operative Wound Infection 33 33
Abscess 31 31
Obstruction/Occlusion 31 31
Nerve Damage 28 28
Unintended Radiation Exposure 22 25
Superficial (First Degree) Burn 20 29
Perforation 17 17
Device Embedded In Tissue or Plaque 15 15
Pleural Effusion 15 15
Fever 15 15
Swelling/ Edema 14 14
Paresis 14 14
Partial thickness (Second Degree) Burn 13 13
Abdominal Pain 13 13
Laceration(s) 12 12
Urinary Retention 11 11
Speech Disorder 10 10
Inflammation 9 9
Tissue Breakdown 9 9
Anemia 9 9
Necrosis 9 9
Hernia 9 9
Impaired Healing 8 11
Bacterial Infection 8 8
Pneumothorax 8 8
Nausea 8 8
Sepsis 8 8
Dysphagia/ Odynophagia 7 7
Pneumonia 7 7
Thrombosis/Thrombus 7 7
Paralysis 7 7
Abdominal Distention 6 6
Low Blood Pressure/ Hypotension 6 6
Bowel Burn 6 6
Rupture 6 6
Vomiting 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 Integra LifeSciences Corp. (NeuroSciences) II Apr-17-2026
6 Olympus Corporation of the Americas II Feb-17-2026
7 Olympus Corporation of the Americas II Jan-21-2025
8 Olympus Corporation of the Americas II Oct-12-2023
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