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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
ALLEVION MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CIT ORTHO
  SUBSTANTIALLY EQUIVALENT 1
CLARUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
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 2
HEMODIA SAS
  SUBSTANTIALLY EQUIVALENT 2
HYDROCISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTRAVU, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CHANGMEI MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOINT PRESERVATION INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LESSPINE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAGING INTEGRATED SOLUTION, INC (MIIS)
  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
SHANGHAI LANGE MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SONEX HEALTH
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY
  SUBSTANTIALLY EQUIVALENT 1
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERTOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1908 1909
2022 1406 1407
2023 1852 1852
2024 2427 2430
2025 2105 2105
2026 1140 1140

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1487 1488
Display or Visual Feedback Problem 1022 1022
Optical Problem 991 991
Use of Device Problem 897 897
Increase in Pressure 723 724
Crack 479 479
Electrical /Electronic Property Problem 464 465
Improper Flow or Infusion 428 428
Infusion or Flow Problem 424 424
Pressure Problem 383 383
Overheating of Device 379 379
Detachment of Device or Device Component 377 377
Output Problem 369 369
Scratched Material 340 340
Appropriate Device Problem Term/Code Not Available 281 281
Device-Device Incompatibility 252 252
Material Rupture 237 237
Mechanical Problem 231 231
Leak/Splash 226 226
Mechanical Jam 220 220
Defective Device 186 186
Excess Flow or Over-Infusion 181 181
Overfill 175 175
Physical Resistance/Sticking 174 174
Device Contaminated During Manufacture or Shipping 163 163
Material Deformation 154 154
Noise, Audible 150 150
Poor Quality Image 149 149
Electrical Shorting 147 147
Device Remains Activated 140 140
Material Fragmentation 113 113
Suction Failure 97 97
Material Frayed 93 93
Fracture 85 86
Fogging 84 84
Material Disintegration 81 81
No Flow 80 80
Contamination /Decontamination Problem 75 75
Material Integrity Problem 73 73
Adverse Event Without Identified Device or Use Problem 68 68
Inflation Problem 65 65
No Display/Image 62 62
Intermittent Loss of Power 61 61
Blocked Connection 60 60
Power Problem 52 52
Mechanics Altered 52 52
Unintended Movement 50 50
Material Twisted/Bent 46 46
Pumping Problem 45 45
Unexpected Shutdown 45 45

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9971 9974
Insufficient Information 380 380
Swelling/ Edema 223 223
Extravasation 160 161
Foreign Body In Patient 100 100
Unspecified Tissue Injury 26 27
Device Embedded In Tissue or Plaque 17 17
Pain 16 16
Hematoma 16 16
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 15 15
Burn(s) 14 14
Unspecified Infection 13 13
Hemorrhage/Blood Loss/Bleeding 11 11
Laceration(s) 9 9
Cerebrospinal Fluid Leakage 7 7
Loss of Range of Motion 6 6
Inflammation 6 6
Numbness 5 5
Pneumothorax 5 5
Joint Dislocation 5 5
Neuropathy 4 4
Infiltration into Tissue 4 4
Failure of Implant 4 4
Nerve Damage 4 4
Bone Fracture(s) 3 3
Compartment syndrome 3 3
Superficial (First Degree) Burn 3 3
Muscle Weakness/Atrophy 2 2
Spinal Cord Injury 2 2
Shock 2 2
Muscle/Tendon Damage 2 2
Dural Tear 2 2
Inadequate Osseointegration 2 2
Discomfort 2 2
Paralysis 2 2
Movement Disorder 2 2
Post Operative Wound Infection 2 2
Spinal Column Injury 2 2
Cardiac Arrest 2 2
Rupture 2 2
Cardiovascular Dysfunction/Insufficiency 1 1
Joint effusion 1 1
Atrophy 1 1
Exposure to Body Fluids 1 1
Pleural Effusion 1 1
Septic Shock 1 1
Swelling 1 1
Back pain 1 1
Pneumocephalus 1 1
Electric Shock 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 ReNovo, Inc. II Mar-02-2021
6 WOM World Of Medicine AG II Jul-01-2024
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