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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device arthroscope
Regulation Description 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
ADVANCED MEDICAL SYSTEMS GROUP SRL
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
CIT ORTHO
  SUBSTANTIALLY EQUIVALENT 1
CLARUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
E SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EBERLE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
HAND BIOMECHANICS LAB, INC
  SUBSTANTIALLY EQUIVALENT 1
HEMODIA SAS
  SUBSTANTIALLY EQUIVALENT 3
HYDROCISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTRAVU, 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
MICROAIRE SURGICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
OK MEDINET KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
RAFAEL MEDICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERTOS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1706 1706
2021 1908 1908
2022 1407 1407
2023 1852 1852
2024 2427 2427
2025 917 917

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1486 1486
Display or Visual Feedback Problem 852 852
Optical Problem 802 802
Use of Device Problem 771 771
Increase in Pressure 599 599
Electrical /Electronic Property Problem 447 447
Detachment of Device or Device Component 388 388
Improper Flow or Infusion 384 384
Infusion or Flow Problem 356 356
Overheating of Device 354 354
Crack 353 353
Device-Device Incompatibility 313 313
Pressure Problem 308 308
Output Problem 304 304
Poor Quality Image 297 297
Scratched Material 258 258
Electrical Shorting 239 239
Appropriate Term/Code Not Available 235 235
Leak/Splash 229 229
Mechanical Problem 206 206
Mechanical Jam 201 201
Defective Device 186 186
Material Rupture 179 179
Overfill 174 174
Physical Resistance/Sticking 162 162
Device Remains Activated 136 136
Excess Flow or Over-Infusion 132 132
Device Contaminated During Manufacture or Shipping 127 127
Material Deformation 124 124
Noise, Audible 119 119
Adverse Event Without Identified Device or Use Problem 108 108
Corroded 102 102
Material Disintegration 100 100
Suction Failure 99 99
Material Frayed 90 90
No Display/Image 84 84
Fracture 76 76
Contamination /Decontamination Problem 73 73
Inflation Problem 58 58
Intermittent Loss of Power 57 57
Degraded 56 56
Mechanics Altered 50 50
Material Integrity Problem 49 49
Entrapment of Device 47 47
Fluid/Blood Leak 47 47
Fogging 47 47
Unintended Movement 47 47
Pumping Problem 45 45
Connection Problem 44 44
Power Problem 44 44

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8243 8243
No Consequences Or Impact To Patient 714 714
Insufficient Information 326 326
No Known Impact Or Consequence To Patient 238 238
No Patient Involvement 208 208
Swelling/ Edema 152 152
Extravasation 144 144
Foreign Body In Patient 127 127
Not Applicable 106 106
No Information 30 30
No Code Available 27 27
Unspecified Tissue Injury 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Device Embedded In Tissue or Plaque 18 18
Burn(s) 18 18
Hematoma 17 17
Unspecified Infection 14 14
Injury 12 12
Pain 12 12
Hemorrhage/Bleeding 11 11
Swelling 11 11
Laceration(s) 9 9
Bone Fracture(s) 8 8
Cerebrospinal Fluid Leakage 7 7
Inflammation 6 6
Tissue Damage 5 5
Failure of Implant 4 4
Infiltration into Tissue 4 4
Edema 4 4
Loss of Range of Motion 4 4
Numbness 4 4
Joint Dislocation 3 3
Nerve Damage 3 3
Superficial (First Degree) Burn 2 2
Inadequate Osseointegration 2 2
Rupture 2 2
Movement Disorder 2 2
Spinal Column Injury 2 2
Shock 2 2
Neuropathy 2 2
Muscular Rigidity 2 2
Post Operative Wound Infection 2 2
Spinal Cord Injury 2 2
Joint Swelling 2 2
Muscle/Tendon Damage 2 2
Electric Shock 1 1
Muscle Weakness 1 1
Extubate 1 1
Impaired Healing 1 1
Non-union Bone Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ADRIA SRL II Oct-19-2021
2 Karl Storz Endoscopy II Nov-25-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
4 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
5 Medtronic Sofamor Danek USA Inc II Jun-16-2020
6 ReNovo, Inc. II Mar-02-2021
7 Smith & Nephew, Inc. II Jul-24-2020
8 WOM World Of Medicine AG II Jul-01-2024
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