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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
CIT ORTHO
  SUBSTANTIALLY EQUIVALENT 1
E SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EBERLE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HAND BIOMECHANICS LAB, INC
  SUBSTANTIALLY EQUIVALENT 1
HEMODIA SAS
  SUBSTANTIALLY EQUIVALENT 3
HYDROCISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRATED ENDOSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
IZI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CHANGMEI MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
OK MEDINET KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISEON, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1676 1676
2020 1706 1706
2021 1908 1908
2022 1407 1407
2023 1853 1853
2024 180 180

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1142 1142
Display or Visual Feedback Problem 581 581
Use of Device Problem 517 517
Increase in Pressure 445 445
Electrical Shorting 428 428
Poor Quality Image 405 405
Electrical /Electronic Property Problem 389 389
Detachment of Device or Device Component 389 389
Overheating of Device 351 351
Device-Device Incompatibility 299 299
Optical Problem 296 296
Improper Flow or Infusion 246 246
Crack 240 240
Infusion or Flow Problem 233 233
Material Rupture 210 210
Output Problem 209 209
Leak/Splash 202 202
Appropriate Term/Code Not Available 197 197
Overfill 191 191
Mechanical Jam 185 185
Pressure Problem 179 179
Mechanical Problem 169 169
Suction Failure 144 144
Physical Resistance/Sticking 135 135
Scratched Material 134 134
Material Disintegration 132 132
Excess Flow or Over-Infusion 121 121
No Display/Image 109 109
Corroded 105 105
Adverse Event Without Identified Device or Use Problem 100 100
Device Remains Activated 87 87
Fluid/Blood Leak 86 86
Defective Device 83 83
Material Frayed 75 75
Noise, Audible 70 70
Intermittent Continuity 64 64
Material Deformation 62 62
Device Contaminated During Manufacture or Shipping 58 58
Inflation Problem 57 57
Insufficient Information 53 53
Fracture 52 52
Entrapment of Device 48 48
Intermittent Loss of Power 48 48
Degraded 46 46
Material Fragmentation 43 43
Mechanics Altered 41 41
Smoking 40 40
Communication or Transmission Problem 38 38
Connection Problem 38 38
Unintended Movement 37 37
Power Problem 35 35
Material Integrity Problem 35 35
Contamination /Decontamination Problem 35 35
Particulates 33 33
Decrease in Pressure 31 31
Optical Obstruction 31 31
Unexpected Shutdown 29 29
Peeled/Delaminated 28 28
Material Twisted/Bent 26 26
Fogging 25 25
Protective Measures Problem 24 24
Device Contamination with Chemical or Other Material 24 24
Failure to Power Up 23 23
Material Separation 23 23
Pumping Problem 22 22
Positioning Problem 22 22
Moisture Damage 21 21
Loss of or Failure to Bond 20 20
Defective Component 20 20
Electrical Power Problem 20 20
Calibration Problem 19 19
Insufficient Flow or Under Infusion 18 18
Blocked Connection 18 18
Self-Activation or Keying 18 18
Delivered as Unsterile Product 17 17
Therapeutic or Diagnostic Output Failure 17 17
Key or Button Unresponsive/not Working 14 14
Incomplete or Inadequate Connection 13 13
Difficult to Open or Close 13 13
Loose or Intermittent Connection 13 13
Circuit Failure 13 13
Deflation Problem 13 13
Material Puncture/Hole 13 13
Component Missing 13 13
Dent in Material 12 12
Nonstandard Device 12 12
Patient Device Interaction Problem 12 12
No Apparent Adverse Event 11 11
Fail-Safe Problem 11 11
Misfocusing 11 11
Erratic or Intermittent Display 11 11
Unintended Power Up 11 11
Suction Problem 11 11
Device Damaged Prior to Use 10 10
Difficult to Insert 10 10
Intermittent Energy Output 10 10
Failure to Clean Adequately 10 10
No Flow 9 9
Material Opacification 9 9
Inaccurate Flow Rate 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5342 5342
No Consequences Or Impact To Patient 1624 1624
No Known Impact Or Consequence To Patient 592 592
No Patient Involvement 421 421
Not Applicable 221 221
Insufficient Information 219 219
Foreign Body In Patient 129 129
Extravasation 109 109
Swelling/ Edema 88 88
No Code Available 44 44
Swelling 39 39
No Information 35 35
Burn(s) 24 24
Unspecified Tissue Injury 23 23
Unspecified Infection 22 22
Device Embedded In Tissue or Plaque 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Injury 14 14
Pain 14 14
Hematoma 9 9
Hemorrhage/Bleeding 9 9
Tissue Damage 9 9
Bone Fracture(s) 9 9
Inflammation 9 9
Laceration(s) 9 9
Edema 8 8
Loss of Range of Motion 7 7
Numbness 6 6
Nerve Damage 5 5
Rupture 3 3
Tingling 3 3
Patient Problem/Medical Problem 3 3
Joint Swelling 3 3
Muscular Rigidity 3 3
Exposure to Body Fluids 3 3
Burning Sensation 3 3
Muscle Weakness 3 3
Failure of Implant 2 2
Infiltration into Tissue 2 2
Adhesion(s) 2 2
Inadequate Osseointegration 2 2
Shock 2 2
Movement Disorder 2 2
Pulmonary Embolism 2 2
Spinal Cord Injury 2 2
Bacterial Infection 2 2
Neuropathy 2 2
Cerebrospinal Fluid Leakage 2 2
Discomfort 2 2
Pneumothorax 2 2
Burn, Thermal 2 2
Cardiac Arrest 1 1
Pneumonia 1 1
Limited Mobility Of The Implanted Joint 1 1
Unspecified Nervous System Problem 1 1
Urinary Tract Infection 1 1
Non-union Bone Fracture 1 1
Dyspnea 1 1
Low Blood Pressure/ Hypotension 1 1
Exsanguination 1 1
Septic Shock 1 1
Paresis 1 1
Extubate 1 1
Discharge 1 1
Neck Stiffness 1 1
Urinary Retention 1 1
Arrhythmia 1 1
Arthralgia 1 1
Vascular System (Circulation), Impaired 1 1
Post Operative Wound Infection 1 1
Pleural Effusion 1 1
Skin Discoloration 1 1
Muscle/Tendon Damage 1 1
Deformity/ Disfigurement 1 1
Joint Dislocation 1 1
Superficial (First 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 ReNovo, Inc. II Mar-02-2021
5 Smith & Nephew, Inc. II Jul-24-2020
6 Stryker GmbH II Aug-28-2019
7 Stryker GmbH II Jun-20-2019
8 Stryker Sustainability Solutions II Mar-05-2019
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