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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
BIOPSYBELL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CIT ORTHO
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  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
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
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
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

MDR Year MDR Reports MDR Events
2018 1581 1682
2019 1676 1676
2020 1706 1706
2021 1908 1908
2022 1414 1414
2023 496 496

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1042 1042
Electrical Shorting 559 559
Display or Visual Feedback Problem 467 467
Increase in Pressure 416 416
Use of Device Problem 411 411
Poor Quality Image 401 401
Detachment of Device or Device Component 380 386
Electrical /Electronic Property Problem 356 356
Overheating of Device 319 335
Overfill 302 302
Device-Device Incompatibility 271 271
Material Rupture 264 264
Optical Problem 246 246
Appropriate Term/Code Not Available 200 200
Crack 197 197
Leak/Splash 195 212
Suction Failure 191 191
Improper Flow or Infusion 185 185
Mechanical Jam 181 190
Material Disintegration 181 190
Output Problem 159 159
Mechanical Problem 152 152
Infusion or Flow Problem 150 150
Fluid/Blood Leak 129 134
No Display/Image 127 127
Excess Flow or Over-Infusion 119 119
Scratched Material 114 114
Pressure Problem 109 109
Corroded 109 109
Physical Resistance/Sticking 107 111
Adverse Event Without Identified Device or Use Problem 104 104
Intermittent Continuity 86 86
Device Remains Activated 78 80
Suction Problem 60 60
Material Frayed 60 60
Positioning Problem 60 78
Intermittent Loss of Power 60 60
Noise, Audible 57 57
Failure to Power Up 55 55
Inflation Problem 54 54
Insufficient Information 52 52
Material Fragmentation 51 55
Peeled/Delaminated 49 49
Degraded 45 45
Material Deformation 45 45
Intermittent Energy Output 43 43
Entrapment of Device 43 43
Smoking 43 43
Fracture 39 39
Device Contaminated During Manufacture or Shipping 38 38
Mechanics Altered 38 38
Communication or Transmission Problem 37 37
Unintended Movement 37 37
Particulates 34 34
Connection Problem 33 33
Contamination /Decontamination Problem 32 32
Filling Problem 32 32
Power Problem 30 30
Optical Obstruction 30 30
Material Twisted/Bent 29 29
Device Contamination with Chemical or Other Material 28 28
Loss of or Failure to Bond 27 27
Defective Component 26 26
Fail-Safe Problem 26 26
Material Integrity Problem 26 26
Protective Measures Problem 25 25
Self-Activation or Keying 25 25
Unintended System Motion 24 24
Electrical Power Problem 24 24
Device Stops Intermittently 23 23
Loose or Intermittent Connection 23 23
Decrease in Pressure 21 21
Defective Device 21 21
Moisture Damage 20 20
Fogging 20 20
Pumping Problem 20 20
Device Displays Incorrect Message 19 19
Circuit Failure 18 18
Image Display Error/Artifact 17 17
Material Separation 17 17
Calibration Problem 17 17
Device Operates Differently Than Expected 17 17
Therapeutic or Diagnostic Output Failure 16 16
Metal Shedding Debris 16 24
Delivered as Unsterile Product 16 16
Unintended Power Up 16 34
Deflation Problem 16 16
Disassembly 15 27
Material Puncture/Hole 15 15
Insufficient Flow or Under Infusion 14 14
Incomplete or Inadequate Connection 14 14
Component Missing 13 13
Material Opacification 13 13
Device Emits Odor 12 12
Misfocusing 12 12
Dent in Material 12 12
No Apparent Adverse Event 11 11
Temperature Problem 11 11
Blocked Connection 11 11
Failure to Clean Adequately 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3990 3990
No Consequences Or Impact To Patient 2533 2551
No Known Impact Or Consequence To Patient 1064 1116
No Patient Involvement 544 587
Not Applicable 266 266
Foreign Body In Patient 144 144
Insufficient Information 118 118
Extravasation 87 87
Swelling/ Edema 66 66
No Code Available 52 52
No Information 43 43
Swelling 42 43
Device Embedded In Tissue or Plaque 27 27
Unspecified Infection 22 22
Unspecified Tissue Injury 21 21
Burn(s) 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Pain 16 16
Injury 15 15
Tissue Damage 11 11
Bone Fracture(s) 11 11
Edema 10 10
Inflammation 9 9
Hemorrhage/Bleeding 8 8
Hematoma 7 7
Loss of Range of Motion 7 7
Nerve Damage 5 5
Laceration(s) 5 5
Rupture 4 4
Numbness 4 4
Joint Swelling 3 3
Burning Sensation 3 3
Tingling 3 3
Patient Problem/Medical Problem 3 3
Burn, Thermal 3 3
Muscle Weakness 3 3
Muscular Rigidity 3 3
Exposure to Body Fluids 3 3
Dyspnea 3 3
Infiltration into Tissue 2 2
Bacterial Infection 2 2
Pulmonary Embolism 2 2
Adhesion(s) 2 2
Failure of Implant 2 2
Inadequate Osseointegration 2 2
Dizziness 2 2
Spinal Cord Injury 2 2
Neck Stiffness 1 1
Post Operative Wound Infection 1 1
Collapse 1 1
Deformity/ Disfigurement 1 1
Non-union Bone Fracture 1 1
Extubate 1 1
Arthralgia 1 1
Discharge 1 1
Discomfort 1 1
Limited Mobility Of The Implanted Joint 1 1
Superficial (First Degree) Burn 1 1
Electric Shock 1 1
Chemical Exposure 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Unspecified Nervous System Problem 1 1
Muscle/Tendon Damage 1 1
Arrhythmia 1 1
Exsanguination 1 1
Cardiac Arrest 1 1
Cerebrospinal Fluid Leakage 1 1
Paresis 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Septic Shock 1 1
Shock 1 1
Skin Discoloration 1 1
Urinary Retention 1 1
Urinary Tract Infection 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 ReNovo, Inc. II Mar-02-2021
6 Richard Wolf GmbH II Aug-22-2018
7 Smith & Nephew, Inc. II Jul-24-2020
8 Stryker GmbH II Aug-28-2019
9 Stryker GmbH II Jun-20-2019
10 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
11 Stryker Sustainability Solutions II Mar-05-2019
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