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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 2427 2427
2025 252 252

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1380 1380
Display or Visual Feedback Problem 785 785
Use of Device Problem 722 722
Optical Problem 696 696
Increase in Pressure 546 546
Electrical /Electronic Property Problem 434 434
Detachment of Device or Device Component 364 364
Improper Flow or Infusion 345 345
Infusion or Flow Problem 335 335
Overheating of Device 332 332
Crack 323 323
Device-Device Incompatibility 312 312
Poor Quality Image 296 296
Pressure Problem 276 276
Output Problem 274 274
Electrical Shorting 238 238
Scratched Material 230 230
Appropriate Term/Code Not Available 224 224
Leak/Splash 216 216
Mechanical Problem 194 194
Mechanical Jam 191 191
Defective Device 175 175
Overfill 165 165
Material Rupture 163 163
Physical Resistance/Sticking 153 153
Device Contaminated During Manufacture or Shipping 121 121
Material Deformation 116 116
Device Remains Activated 112 112
Excess Flow or Over-Infusion 112 112
Adverse Event Without Identified Device or Use Problem 105 105
Corroded 102 102
Material Disintegration 100 100
Noise, Audible 99 99
Suction Failure 93 93
Material Frayed 89 89
No Display/Image 82 82
Fracture 72 72
Contamination /Decontamination Problem 64 64
Inflation Problem 55 55
Degraded 53 53
Intermittent Loss of Power 53 53
Mechanics Altered 49 49
Entrapment of Device 47 47
Fluid/Blood Leak 44 44
Connection Problem 44 44
Pumping Problem 43 43
Power Problem 42 42
Unexpected Shutdown 42 42
Fogging 41 41
Material Integrity Problem 41 41

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7638 7638
No Consequences Or Impact To Patient 714 714
Insufficient Information 304 304
No Known Impact Or Consequence To Patient 238 238
No Patient Involvement 208 208
Extravasation 135 135
Swelling/ Edema 131 131
Foreign Body In Patient 123 123
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
Burn(s) 18 18
Device Embedded In Tissue or Plaque 17 17
Hematoma 16 16
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 5 5
Tissue Damage 5 5
Failure of Implant 4 4
Loss of Range of Motion 4 4
Edema 4 4
Joint Dislocation 3 3
Infiltration into Tissue 3 3
Numbness 3 3
Spinal Cord Injury 2 2
Inadequate Osseointegration 2 2
Muscular Rigidity 2 2
Neuropathy 2 2
Shock 2 2
Nerve Damage 2 2
Joint Swelling 2 2
Spinal Column Injury 2 2
Movement Disorder 2 2
Post Operative Wound Infection 2 2
Muscle/Tendon Damage 2 2
Rupture 2 2
Superficial (First Degree) Burn 2 2
Low Blood Pressure/ Hypotension 1 1
Paralysis 1 1
Skin Infection 1 1
Muscle Weakness 1 1
Intervertebral Disc Compression or Protrusion 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 Sep-06-2024
4 Medtronic Sofamor Danek USA Inc II Jun-16-2020
5 ReNovo, Inc. II Mar-02-2021
6 Smith & Nephew, Inc. II Jul-24-2020
7 WOM World Of Medicine AG II Jul-01-2024
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