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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
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 1853 1853
2024 2428 2428
2025 565 565

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1437 1437
Display or Visual Feedback Problem 810 810
Use of Device Problem 747 747
Optical Problem 744 744
Increase in Pressure 566 566
Electrical /Electronic Property Problem 439 439
Detachment of Device or Device Component 372 372
Improper Flow or Infusion 363 363
Infusion or Flow Problem 344 344
Overheating of Device 342 342
Crack 337 337
Device-Device Incompatibility 312 312
Poor Quality Image 296 296
Pressure Problem 295 295
Output Problem 281 281
Scratched Material 244 244
Electrical Shorting 238 238
Appropriate Term/Code Not Available 230 230
Leak/Splash 221 221
Mechanical Jam 197 197
Mechanical Problem 197 197
Defective Device 180 180
Material Rupture 167 167
Overfill 166 166
Physical Resistance/Sticking 156 156
Device Contaminated During Manufacture or Shipping 125 125
Device Remains Activated 124 124
Excess Flow or Over-Infusion 124 124
Material Deformation 120 120
Noise, Audible 107 107
Adverse Event Without Identified Device or Use Problem 106 106
Corroded 102 102
Material Disintegration 100 100
Suction Failure 97 97
Material Frayed 91 91
No Display/Image 83 83
Fracture 75 75
Contamination /Decontamination Problem 67 67
Inflation Problem 57 57
Degraded 54 54
Intermittent Loss of Power 54 54
Mechanics Altered 49 49
Material Integrity Problem 47 47
Entrapment of Device 47 47
Fluid/Blood Leak 47 47
Connection Problem 44 44
Fogging 43 43
Unexpected Shutdown 43 43
Pumping Problem 43 43
Power Problem 43 43

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7922 7922
No Consequences Or Impact To Patient 714 714
Insufficient Information 321 321
No Known Impact Or Consequence To Patient 238 238
No Patient Involvement 208 208
Swelling/ Edema 138 138
Extravasation 138 138
Foreign Body In Patient 126 126
Not Applicable 106 106
No Information 30 30
Unspecified Tissue Injury 27 27
No Code Available 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
Pain 12 12
Injury 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
Edema 4 4
Loss of Range of Motion 4 4
Nerve Damage 4 4
Infiltration into Tissue 3 3
Numbness 3 3
Joint Dislocation 3 3
Neuropathy 2 2
Movement Disorder 2 2
Post Operative Wound Infection 2 2
Muscular Rigidity 2 2
Spinal Column Injury 2 2
Rupture 2 2
Joint Swelling 2 2
Spinal Cord Injury 2 2
Superficial (First Degree) Burn 2 2
Inadequate Osseointegration 2 2
Muscle/Tendon Damage 2 2
Shock 2 2
Urinary Tract Infection 1 1
Pulmonary Embolism 1 1
Vertebral Fracture 1 1
Low Blood Pressure/ Hypotension 1 1
Extubate 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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