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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
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOPSYBELL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CIT ORTHO
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
E SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EBERLE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ELLIQUENCE, LLC
  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
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
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
MICROAIRE SURGICAL INSTRUMENTS LLC
  SUBSTANTIALLY EQUIVALENT 1
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
OK MEDINET KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
RENOVO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISEON, INC.
  SUBSTANTIALLY EQUIVALENT 2
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
WEMED BIO-TECH INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 934 1063
2018 1581 1682
2019 1676 1676
2020 1706 1706
2021 1908 1908
2022 1407 1407
2023 1853 1853
2024 539 539

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1369 1370
Electrical Shorting 638 638
Display or Visual Feedback Problem 636 636
Use of Device Problem 589 589
Increase in Pressure 562 562
Poor Quality Image 518 518
Overheating of Device 441 477
Detachment of Device or Device Component 429 435
Electrical /Electronic Property Problem 417 417
Material Rupture 380 380
Overfill 344 344
Device-Device Incompatibility 315 315
Optical Problem 307 307
Improper Flow or Infusion 274 274
Leak/Splash 266 292
Crack 257 257
Pressure Problem 251 251
Infusion or Flow Problem 248 248
Appropriate Term/Code Not Available 241 241
No Display/Image 227 227
Output Problem 219 219
Suction Failure 218 218
Mechanical Jam 218 227
Mechanical Problem 196 196
Material Disintegration 181 190
Scratched Material 165 165
Excess Flow or Over-Infusion 153 153
Adverse Event Without Identified Device or Use Problem 150 150
Physical Resistance/Sticking 146 150
Fluid/Blood Leak 133 138
Defective Device 131 131
Device Operates Differently Than Expected 122 124
Corroded 109 109
Device Remains Activated 102 107
Intermittent Loss of Power 93 93
Intermittent Continuity 87 87
Noise, Audible 85 85
Suction Problem 83 83
Material Fragmentation 79 83
Material Frayed 78 78
Material Deformation 70 70
Insufficient Information 63 63
Smoking 63 63
Failure to Power Up 62 62
Positioning Problem 62 105
Inflation Problem 61 61
Device Contaminated During Manufacture or Shipping 60 60
Fracture 55 55
Peeled/Delaminated 53 53
Unintended Movement 50 50
Entrapment of Device 49 49
Degraded 46 46
Connection Problem 44 44
Intermittent Energy Output 43 43
Device Displays Incorrect Message 42 42
Metal Shedding Debris 42 92
Mechanics Altered 41 41
Communication or Transmission Problem 39 39
Self-Activation or Keying 39 39
Contamination /Decontamination Problem 38 38
Material Integrity Problem 37 37
Unexpected Shutdown 36 36
Power Problem 36 36
Disassembly 36 63
Fogging 36 36
Filling Problem 35 35
Decrease in Pressure 35 35
Particulates 35 35
Defective Component 34 34
Device Contamination with Chemical or Other Material 33 33
Optical Obstruction 32 32
Material Twisted/Bent 31 31
Pumping Problem 28 28
Device Stops Intermittently 28 28
Detachment Of Device Component 27 27
Loss of or Failure to Bond 27 27
Circuit Failure 26 26
Moisture Damage 26 26
Loose or Intermittent Connection 26 26
Fail-Safe Problem 26 26
Electrical Power Problem 25 25
Protective Measures Problem 25 25
Material Separation 25 25
Unintended System Motion 25 25
Calibration Problem 24 24
Temperature Problem 22 22
Image Display Error/Artifact 22 22
Unintended Power Up 21 52
Material Opacification 20 20
Delivered as Unsterile Product 20 20
Insufficient Flow or Under Infusion 20 20
Blocked Connection 20 20
Device Inoperable 19 19
Component Missing 17 17
Therapeutic or Diagnostic Output Failure 17 17
Key or Button Unresponsive/not Working 17 17
Material Puncture/Hole 16 16
Deflation Problem 16 16
Thermal Decomposition of Device 16 16
Device Emits Odor 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5683 5683
No Consequences Or Impact To Patient 2637 2709
No Known Impact Or Consequence To Patient 1645 1721
No Patient Involvement 603 697
Not Applicable 268 268
Insufficient Information 228 228
Foreign Body In Patient 176 176
No Information 144 144
Extravasation 136 136
Swelling/ Edema 96 96
No Code Available 71 71
Swelling 58 59
Device Embedded In Tissue or Plaque 51 51
Burn(s) 30 30
Unspecified Infection 28 28
Pain 25 25
Unspecified Tissue Injury 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Injury 19 19
Tissue Damage 18 18
Edema 13 13
Bone Fracture(s) 12 12
Hematoma 11 11
Hemorrhage/Bleeding 9 9
Inflammation 9 9
Laceration(s) 9 9
Loss of Range of Motion 7 7
Numbness 7 7
Nerve Damage 5 5
Joint Swelling 4 4
Rupture 4 4
Burning Sensation 3 3
Tingling 3 3
Failure of Implant 3 3
Discomfort 3 3
Burn, Thermal 3 3
Muscle Weakness 3 3
Muscular Rigidity 3 3
Dyspnea 3 3
Pulmonary Embolism 3 3
Exposure to Body Fluids 3 3
Patient Problem/Medical Problem 3 3
Inadequate Osseointegration 2 2
Movement Disorder 2 2
Bacterial Infection 2 2
Adhesion(s) 2 2
Cerebrospinal Fluid Leakage 2 2
Erythema 2 2
Neuropathy 2 2
Infiltration into Tissue 2 2
Pneumothorax 2 2
Paralysis 2 2
Spinal Cord Injury 2 2
Electric Shock 2 2
Dizziness 2 2
Shock 2 2
Skin Discoloration 2 2
Skin Erosion 1 1
Spinal Column Injury 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Visual Impairment 1 1
Brain Injury 1 1
Discharge 1 1
Chemical Exposure 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Neck Stiffness 1 1
Post Operative Wound Infection 1 1
Ambulation Difficulties 1 1
Deformity/ Disfigurement 1 1
Non-union Bone Fracture 1 1
Joint Dislocation 1 1
Inadequate Pain Relief 1 1
Extubate 1 1
Collapse 1 1
Arthralgia 1 1
Paresis 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Pulmonary Edema 1 1
Scarring 1 1
Septic Shock 1 1
Exsanguination 1 1
Fall 1 1
Low Blood Pressure/ Hypotension 1 1
Cardiac Arrest 1 1
Arrhythmia 1 1
Unspecified Nervous System Problem 1 1
Muscle/Tendon Damage 1 1
Limited Mobility Of The Implanted Joint 1 1
Superficial (First Degree) Burn 1 1
Full thickness (Third 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 MicroAire Surgical Instruments, LLC II May-25-2018
5 Myelotec, Inc. II Jul-28-2017
6 ReNovo, Inc. II Mar-02-2021
7 Richard Wolf GmbH II Aug-22-2018
8 Smith & Nephew, Inc. II Jul-24-2020
9 Stryker GmbH II Aug-28-2019
10 Stryker GmbH II Jun-20-2019
11 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
12 Stryker Sustainability Solutions II Mar-05-2019
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