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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
CIT ORTHO
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
E SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EBERLE GMBH & CO. KG
  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
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
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
OK MEDINET KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISEON, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 1199 1199
Display or Visual Feedback Problem 634 634
Use of Device Problem 586 586
Increase in Pressure 473 473
Electrical Shorting 430 430
Poor Quality Image 412 412
Detachment of Device or Device Component 396 396
Electrical /Electronic Property Problem 392 392
Overheating of Device 359 359
Device-Device Incompatibility 308 308
Optical Problem 306 306
Improper Flow or Infusion 270 270
Infusion or Flow Problem 246 246
Crack 246 246
Output Problem 219 219
Material Rupture 216 216
Leak/Splash 208 208
Appropriate Term/Code Not Available 205 205
Overfill 204 204
Pressure Problem 194 194
Mechanical Jam 187 187
Mechanical Problem 171 171
Suction Failure 148 148
Scratched Material 146 146
Physical Resistance/Sticking 138 138
Material Disintegration 132 132
Defective Device 131 131
Excess Flow or Over-Infusion 124 124
No Display/Image 110 110
Corroded 105 105
Adverse Event Without Identified Device or Use Problem 102 102
Device Remains Activated 88 88
Fluid/Blood Leak 87 87
Material Frayed 77 77
Noise, Audible 75 75
Material Deformation 70 70
Intermittent Continuity 64 64
Device Contaminated During Manufacture or Shipping 60 60
Inflation Problem 57 57
Insufficient Information 53 53
Fracture 52 52
Entrapment of Device 48 48
Intermittent Loss of Power 48 48
Degraded 46 46
Material Fragmentation 43 43
Smoking 41 41
Mechanics Altered 41 41
Connection Problem 40 40
Unintended Movement 39 39
Communication or Transmission Problem 38 38
Material Integrity Problem 37 37
Contamination /Decontamination Problem 35 35
Power Problem 35 35
Decrease in Pressure 34 34
Particulates 33 33
Unexpected Shutdown 33 33
Optical Obstruction 31 31
Peeled/Delaminated 28 28
Fogging 28 28
Material Twisted/Bent 26 26
Pumping Problem 25 25
Failure to Power Up 25 25
Material Separation 24 24
Moisture Damage 24 24
Protective Measures Problem 24 24
Device Contamination with Chemical or Other Material 24 24
Positioning Problem 22 22
Defective Component 21 21
Loss of or Failure to Bond 20 20
Electrical Power Problem 20 20
Blocked Connection 20 20
Calibration Problem 20 20
Self-Activation or Keying 18 18
Insufficient Flow or Under Infusion 18 18
Delivered as Unsterile Product 17 17
Therapeutic or Diagnostic Output Failure 17 17
Key or Button Unresponsive/not Working 17 17
Loose or Intermittent Connection 14 14
Circuit Failure 13 13
Deflation Problem 13 13
Suction Problem 13 13
Component Missing 13 13
Material Puncture/Hole 13 13
Incomplete or Inadequate Connection 13 13
Difficult to Open or Close 13 13
Patient Device Interaction Problem 12 12
Dent in Material 12 12
Erratic or Intermittent Display 12 12
Nonstandard Device 12 12
Misfocusing 11 11
Unintended Power Up 11 11
No Apparent Adverse Event 11 11
No Flow 11 11
Fail-Safe Problem 11 11
Intermittent Energy Output 10 10
Failure to Clean Adequately 10 10
Difficult to Insert 10 10
Flaked 10 10
Device Damaged Prior to Use 10 10
Unintended System Motion 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5682 5682
No Consequences Or Impact To Patient 1624 1624
No Known Impact Or Consequence To Patient 592 592
No Patient Involvement 421 421
Insufficient Information 228 228
Not Applicable 221 221
Foreign Body In Patient 130 130
Extravasation 113 113
Swelling/ Edema 96 96
No Code Available 44 44
Swelling 39 39
No Information 35 35
Burn(s) 24 24
Unspecified Tissue Injury 23 23
Unspecified Infection 22 22
Device Embedded In Tissue or Plaque 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Pain 15 15
Injury 14 14
Hematoma 10 10
Hemorrhage/Bleeding 9 9
Bone Fracture(s) 9 9
Inflammation 9 9
Laceration(s) 9 9
Tissue Damage 9 9
Edema 8 8
Loss of Range of Motion 7 7
Numbness 6 6
Nerve Damage 5 5
Muscle Weakness 3 3
Muscular Rigidity 3 3
Exposure to Body Fluids 3 3
Joint Swelling 3 3
Rupture 3 3
Burning Sensation 3 3
Tingling 3 3
Patient Problem/Medical Problem 3 3
Movement Disorder 2 2
Burn, Thermal 2 2
Inadequate Osseointegration 2 2
Spinal Cord Injury 2 2
Bacterial Infection 2 2
Pulmonary Embolism 2 2
Adhesion(s) 2 2
Cerebrospinal Fluid Leakage 2 2
Infiltration into Tissue 2 2
Neuropathy 2 2
Failure of Implant 2 2
Pneumothorax 2 2
Shock 2 2
Discomfort 2 2
Skin Discoloration 1 1
Septic Shock 1 1
Paresis 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Low Blood Pressure/ Hypotension 1 1
Exsanguination 1 1
Dyspnea 1 1
Cardiac Arrest 1 1
Arrhythmia 1 1
Neck Stiffness 1 1
Post Operative Wound Infection 1 1
Deformity/ Disfigurement 1 1
Non-union Bone Fracture 1 1
Joint Dislocation 1 1
Extubate 1 1
Discharge 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Limited Mobility Of The Implanted Joint 1 1
Superficial (First Degree) Burn 1 1
Vascular System (Circulation), Impaired 1 1
Arthralgia 1 1
Unspecified Nervous System Problem 1 1
Muscle/Tendon Damage 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 ReNovo, Inc. II Mar-02-2021
5 Smith & Nephew, Inc. II Jul-24-2020
6 Stryker GmbH II Aug-28-2019
7 Stryker GmbH II Jun-20-2019
8 Stryker Sustainability Solutions II Mar-05-2019
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