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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device arthroscope
Definition Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeHRX
Regulation Number 888.1100
Device Class 2


Premarket Reviews
ManufacturerDecision
A.M. SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED MEDICAL SYSTEMS GROUP SRL
  SUBSTANTIALLY EQUIVALENT 1
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOPSYBELL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CIT ORTHO
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EBERLE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ELLIQUENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HAND BIOMECHANICS LAB, INC
  SUBSTANTIALLY EQUIVALENT 1
HEMODIA SAS
  SUBSTANTIALLY EQUIVALENT 2
HYDROCISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRATED ENDOSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTRAVU, INC.
  SUBSTANTIALLY EQUIVALENT 1
IZI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS LLC
  SUBSTANTIALLY EQUIVALENT 1
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
RENOVO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISEON, INC.
  SUBSTANTIALLY EQUIVALENT 2
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
WEMED BIO-TECH INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 934 1063
2018 1581 1682
2019 1676 1676
2020 1706 1706
2021 1908 1908
2022 1156 1156

Device Problems MDRs with this Device Problem Events in those MDRs
Break 990 991
Electrical Shorting 617 617
Poor Quality Image 450 450
Increase in Pressure 384 384
Display or Visual Feedback Problem 375 375
Material Rupture 344 344
Overheating of Device 336 372
Detachment of Device or Device Component 330 336
Use of Device Problem 322 322
Overfill 291 291
Electrical /Electronic Property Problem 278 278
Device-Device Incompatibility 243 243
No Display/Image 215 215
Leak/Splash 212 238
Suction Failure 195 195
Optical Problem 194 194
Appropriate Term/Code Not Available 193 193
Material Disintegration 183 192
Crack 178 178
Mechanical Jam 167 176
Improper Flow or Infusion 153 153
Adverse Event Without Identified Device or Use Problem 131 131
Fluid/Blood Leak 131 136
Device Operates Differently Than Expected 122 124
Mechanical Problem 119 119
Pressure Problem 118 118
Excess Flow or Over-Infusion 114 114
Output Problem 113 113
Infusion or Flow Problem 113 113
Corroded 109 109
Scratched Material 101 101
Intermittent Continuity 87 87
Physical Resistance/Sticking 86 90
Suction Problem 77 77
Device Remains Activated 75 80
Material Fragmentation 69 73
Positioning Problem 62 105
Intermittent Loss of Power 61 61
Insufficient Information 60 60
Failure to Power Up 56 56
Material Frayed 54 54
Noise, Audible 54 54
Smoking 50 50
Peeled/Delaminated 49 49
Inflation Problem 47 47
Material Deformation 44 44
Intermittent Energy Output 43 43
Degraded 43 43
Entrapment of Device 42 42
Metal Shedding Debris 42 92
Device Displays Incorrect Message 41 41
Fracture 40 40
Communication or Transmission Problem 37 37
Disassembly 36 63
Filling Problem 35 35
Connection Problem 35 35
Unintended Movement 35 35
Particulates 34 34
Self-Activation or Keying 34 34
Mechanics Altered 33 33
Device Contamination with Chemical or Other Material 32 32
Material Twisted/Bent 29 29
Power Problem 29 29
Optical Obstruction 28 28
Device Stops Intermittently 28 28
Defective Component 27 27
Loss of or Failure to Bond 27 27
Detachment Of Device Component 27 27
Circuit Failure 26 26
Fail-Safe Problem 26 26
Contamination /Decontamination Problem 26 26
Protective Measures Problem 25 25
Unintended System Motion 25 25
Electrical Power Problem 24 24
Loose or Intermittent Connection 23 23
Device Contaminated During Manufacture or Shipping 22 22
Material Integrity Problem 21 21
Temperature Problem 20 20
Image Display Error/Artifact 20 20
Unintended Power Up 20 51
Decrease in Pressure 20 20
Device Inoperable 19 19
Defective Device 19 19
Pumping Problem 18 18
Material Separation 18 18
Moisture Damage 18 18
Delivered as Unsterile Product 18 18
Material Opacification 17 17
Fogging 17 17
Calibration Problem 17 17
Therapeutic or Diagnostic Output Failure 16 16
Deflation Problem 15 15
Material Puncture/Hole 15 15
Device Emits Odor 14 14
Insufficient Flow or Under Infusion 14 14
Bent 14 14
Incomplete or Inadequate Connection 14 14
Thermal Decomposition of Device 13 13
Sticking 13 20
Component Missing 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3281 3281
No Consequences Or Impact To Patient 2637 2709
No Known Impact Or Consequence To Patient 1645 1721
No Patient Involvement 603 697
Not Applicable 268 268
Foreign Body In Patient 158 158
No Information 144 144
Insufficient Information 96 96
Extravasation 83 83
No Code Available 71 71
Swelling 58 59
Swelling/ Edema 53 53
Device Embedded In Tissue or Plaque 47 47
Unspecified Infection 25 25
Pain 21 21
Burn(s) 20 20
Injury 19 19
Tissue Damage 18 18
Unspecified Tissue Injury 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Edema 13 13
Bone Fracture(s) 10 10
Inflammation 9 9
Loss of Range of Motion 7 7
Nerve Damage 5 5
Laceration(s) 5 5
Hematoma 5 5
Numbness 5 5
Rupture 4 4
Joint Swelling 4 4
Hemorrhage/Bleeding 4 4
Failure of Implant 3 3
Pulmonary Embolism 3 3
Exposure to Body Fluids 3 3
Muscle Weakness 3 3
Muscular Rigidity 3 3
Dyspnea 3 3
Burning Sensation 3 3
Tingling 3 3
Patient Problem/Medical Problem 3 3
Burn, Thermal 3 3
Spinal Cord Injury 2 2
Electric Shock 2 2
Dizziness 2 2
Skin Discoloration 2 2
Paralysis 2 2
Bacterial Infection 2 2
Adhesion(s) 2 2
Erythema 2 2
Discomfort 2 2
Unspecified Nervous System Problem 1 1
Muscle/Tendon Damage 1 1
Exsanguination 1 1
Cardiac Arrest 1 1
Cerebrospinal Fluid Leakage 1 1
Arrhythmia 1 1
Infiltration into Tissue 1 1
Fall 1 1
Paresis 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Skin Erosion 1 1
Spinal Column Injury 1 1
Scarring 1 1
Septic Shock 1 1
Shock 1 1
Arthralgia 1 1
Deformity/ Disfigurement 1 1
Non-union Bone Fracture 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Brain Injury 1 1
Discharge 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Visual Impairment 1 1
Chemical Exposure 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Neck Stiffness 1 1
Post Operative Wound Infection 1 1
Collapse 1 1
Ambulation Difficulties 1 1
Limited Mobility Of The Implanted Joint 1 1
Superficial (First Degree) Burn 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ADRIA SRL II Oct-19-2021
2 Medtronic Sofamor Danek USA Inc II Jun-16-2020
3 MicroAire Surgical Instruments, LLC II Aug-08-2019
4 MicroAire Surgical Instruments, LLC II May-25-2018
5 Myelotec, Inc. II Jul-28-2017
6 ReNovo, Inc. II Mar-02-2021
7 Richard Wolf GmbH II Aug-22-2018
8 Smith & Nephew, Inc. II Jul-24-2020
9 Stryker GmbH II Aug-28-2019
10 Stryker GmbH II Jun-20-2019
11 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
12 Stryker Sustainability Solutions II Mar-05-2019
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