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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
A.M. SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED MEDICAL SYSTEMS GROUP SRL
  SUBSTANTIALLY EQUIVALENT 1
AJU PHARM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  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
HEMODIA SAS
  SUBSTANTIALLY EQUIVALENT 2
HYDROCISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS LLC
  SUBSTANTIALLY EQUIVALENT 1
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
PROSURG, INC
  SUBSTANTIALLY EQUIVALENT 1
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 4
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISEON, INC.
  SUBSTANTIALLY EQUIVALENT 2
VISIONSENSE LTD
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
WEMED BIO-TECH INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 469 524
2017 934 1063
2018 1581 1682
2019 1676 1676
2020 1706 1706
2021 1651 1651

Device Problems MDRs with this Device Problem Events in those MDRs
Break 876 877
Electrical Shorting 520 520
Poor Quality Image 387 387
Material Rupture 386 386
Overheating of Device 306 357
Increase in Pressure 286 286
Detachment of Device or Device Component 259 265
Overfill 255 255
No Display/Image 218 218
Use of Device Problem 196 196
Suction Failure 195 195
Display or Visual Feedback Problem 191 191
Leak/Splash 184 217
Material Disintegration 174 183
Device-Device Incompatibility 173 173
Device Operates Differently Than Expected 156 158
Adverse Event Without Identified Device or Use Problem 151 151
Crack 148 148
Electrical /Electronic Property Problem 138 138
Mechanical Jam 137 146
Appropriate Term/Code Not Available 135 135
Fluid Leak 135 140
Optical Problem 117 117
Pressure Problem 114 114
Corroded 109 109
Excess Flow or Over-Infusion 100 100
Improper Flow or Infusion 88 88
Material Fragmentation 86 90
Intermittent Continuity 86 86
Suction Problem 80 80
Mechanical Problem 79 79
Insufficient Information 74 74
Metal Shedding Debris 65 128
Infusion or Flow Problem 62 62
Positioning Problem 62 105
Intermittent Loss of Power 61 61
Scratched Material 56 56
Physical Resistance/Sticking 54 58
Failure to Power Up 54 54
Device Remains Activated 52 58
Disassembly 52 91
Peeled/Delaminated 51 51
Smoking 46 47
Material Frayed 45 45
Output Problem 45 45
Detachment Of Device Component 44 44
Intermittent Energy Output 43 43
Noise, Audible 42 42
Device Displays Incorrect Message 42 42
Material Deformation 39 39
Degraded 38 38
Inflation Problem 38 38
Filling Problem 35 35
Device Contamination with Chemical or Other Material 35 35
Communication or Transmission Problem 35 35
Unintended Movement 34 34
Entrapment of Device 34 34
Particulates 34 34
Self-Activation or Keying 33 33
Fracture 32 32
Connection Problem 31 31
Device Stops Intermittently 29 29
Defective Component 28 28
Loss of or Failure to Bond 27 27
Circuit Failure 26 26
Unintended System Motion 25 25
Fail-Safe Problem 25 25
Protective Measures Problem 25 25
Electrical Power Problem 24 24
Device Inoperable 23 23
Image Display Error/Artifact 22 22
Loose or Intermittent Connection 21 21
Unintended Power Up 21 58
Optical Obstruction 21 21
Power Problem 20 20
Material Separation 20 20
Mechanics Altered 19 19
Temperature Problem 19 19
Contamination /Decontamination Problem 18 18
Sticking 18 25
Fogging 18 18
Bent 17 17
Component Missing 17 17
Delivered as Unsterile Product 17 17
Material Opacification 17 17
Decrease in Pressure 17 17
Pumping Problem 17 17
Material Twisted/Bent 15 15
Defective Device 15 15
Material Puncture/Hole 15 15
Insufficient Flow or Under Infusion 15 15
Loss of Power 14 14
Therapeutic or Diagnostic Output Failure 14 14
Incomplete or Inadequate Connection 14 14
Thermal Decomposition of Device 13 13
Deflation Problem 13 13
Misfocusing 12 12
Device Emits Odor 11 11
Moisture Damage 10 10
Nonstandard Device 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2673 2756
No Clinical Signs, Symptoms or Conditions 1974 1974
No Known Impact Or Consequence To Patient 1835 1912
No Patient Involvement 667 804
Not Applicable 268 268
No Information 167 167
Foreign Body In Patient 144 144
No Code Available 104 104
Swelling 82 83
Extravasation 70 70
Device Embedded In Tissue or Plaque 64 64
Insufficient Information 59 59
Pain 33 33
Unspecified Infection 31 31
Swelling/ Edema 25 25
Injury 22 22
Tissue Damage 21 21
Burn(s) 20 20
Bone Fracture(s) 18 18
Edema 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Inflammation 7 7
Numbness 7 7
Joint Swelling 6 6
Inadequate Pain Relief 5 5
Nerve Damage 5 5
Hematoma 5 5
Pulmonary Embolism 5 5
Unspecified Tissue Injury 5 5
Patient Problem/Medical Problem 4 4
Paralysis 4 4
Burn, Thermal 4 4
Ambulation Difficulties 4 4
Collapse 3 3
Burning Sensation 3 3
Tingling 3 3
Dizziness 3 3
Discomfort 3 3
Neurological Deficit/Dysfunction 3 3
Loss of Range of Motion 3 3
Muscle Weakness 3 3
Muscular Rigidity 3 3
Dyspnea 3 3
Failure of Implant 3 3
Fever 2 2
Adhesion(s) 2 2
Bacterial Infection 2 2
Exposure to Body Fluids 2 2
Erythema 2 2
Rupture 2 2
Shock 2 2
Skin Discoloration 2 2
Arthralgia 2 2
Electric Shock 2 2
Blood Loss 2 2
Abdominal Distention 1 1
Extubate 1 1
Chemical Exposure 1 1
Vascular System (Circulation), Impaired 1 1
Deformity/ Disfigurement 1 1
Coma 1 1
Spinal Cord Injury 1 1
Neck Stiffness 1 1
Pallor 1 1
Skin Erosion 1 1
Spinal Column Injury 1 1
Urinary Retention 1 1
Visual Impairment 1 1
Weakness 1 1
Brain Injury 1 1
Discharge 1 1
Complaint, Ill-Defined 1 1
Exsanguination 1 1
Fall 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Arrhythmia 1 1
Cardiac Arrest 1 1
Cerebrospinal Fluid Leakage 1 1
Chest Pain 1 1
Cyanosis 1 1
Death 1 1
Foreign Body Sensation in Eye 1 1
Scarring 1 1
Sepsis 1 1
Overdose 1 1
Paresis 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Pneumothorax 1 1
Pulmonary Edema 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 Biomet, Inc. II May-26-2016
3 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jan-15-2016
4 Medical Vision Ab II Aug-30-2016
5 Medtronic Sofamor Danek USA Inc II Jun-16-2020
6 MicroAire Surgical Instruments, LLC II Aug-08-2019
7 MicroAire Surgical Instruments, LLC II May-25-2018
8 Myelotec, Inc. II Jul-28-2017
9 ReNovo, Inc. II Mar-02-2021
10 Richard Wolf GmbH II Aug-22-2018
11 Richard Wolf Medical Instruments Corp. II Feb-09-2016
12 Smith & Nephew, Inc. II Jul-24-2020
13 Stryker GmbH II Aug-28-2019
14 Stryker GmbH II Jun-20-2019
15 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
16 Stryker Sustainability Solutions II Mar-05-2019
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