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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
ALTOMEC ENDOSCOPY INC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASAP ENDOSCOPIC PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
AXIS SURGICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOPSYBELL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BIOVISION TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
BLAZEJEWSKI MEDI-TECH GMBH
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 4
CIT ORTHO
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CONMED LINVATEC
  SUBSTANTIALLY EQUIVALENT 1
CORESPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 3
DEPUY MITEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
E SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EBERLE GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
EFS EBERLE FEINWERKTECHNISCHE SYSTEME
  SUBSTANTIALLY EQUIVALENT 1
ELLIQUENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GALLINI MEDICAL DEVICES, SRL
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HAND BIOMECHANICS LAB, INC
  SUBSTANTIALLY EQUIVALENT 1
HEMODIA S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
HEMODIA SAS
  SUBSTANTIALLY EQUIVALENT 3
HOOGLAND SPINE PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 2
HYDROCISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRATED ENDOSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTRAVU, INC.
  SUBSTANTIALLY EQUIVALENT 1
IZI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU CHANGMEI MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAURIMED LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL VISION AB
  SUBSTANTIALLY EQUIVALENT 1
MEDISISS
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  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
MYELOTEC
  SUBSTANTIALLY EQUIVALENT 1
NLT SPINE LTD
  SUBSTANTIALLY EQUIVALENT 3
OK MEDINET KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SCIENCES, INC
  SUBSTANTIALLY EQUIVALENT 2
OUROBOROS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
PROSURG, INC
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
RENOVO, INC.
  SUBSTANTIALLY EQUIVALENT 1
RZ MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SCHOLLY FIBEROPTIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE VIEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 2
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
THEKEN SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
TRANSCORP, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VERTIFLEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISEON, INC.
  SUBSTANTIALLY EQUIVALENT 2
VISIONSCOPE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
VISIONSENSE LTD
  SUBSTANTIALLY EQUIVALENT 1
VISIONSENSE LTD.
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
WEMED BIO-TECH INC.
  SUBSTANTIALLY EQUIVALENT 1
X-STEN CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 799 799
2015 763 763
2016 469 524
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 1583 1584
Material Rupture 683 683
Electrical Shorting 639 639
Display or Visual Feedback Problem 638 638
Overheating of Device 602 653
Increase in Pressure 601 601
Use of Device Problem 596 596
Poor Quality Image 528 528
Detachment of Device or Device Component 523 529
Electrical /Electronic Property Problem 419 419
Leak/Splash 360 393
Overfill 348 348
Device-Device Incompatibility 315 315
Optical Problem 307 307
Pressure Problem 305 305
Improper Flow or Infusion 278 278
Adverse Event Without Identified Device or Use Problem 277 277
Crack 261 261
Appropriate Term/Code Not Available 256 256
Infusion or Flow Problem 254 254
Device Operates Differently Than Expected 234 236
No Display/Image 234 234
Output Problem 220 220
Suction Failure 218 218
Mechanical Jam 218 227
Mechanical Problem 202 202
Material Disintegration 183 192
Scratched Material 167 167
Excess Flow or Over-Infusion 164 164
Device Remains Activated 159 165
Fluid/Blood Leak 152 157
Physical Resistance/Sticking 146 150
Metal Shedding Debris 138 201
Defective Device 132 132
Insufficient Information 131 131
Material Fragmentation 129 133
Disassembly 110 149
Corroded 109 109
Noise, Audible 102 102
Component Missing 101 101
Intermittent Loss of Power 93 93
Suction Problem 89 89
Intermittent Continuity 88 88
Smoking 86 87
Unknown (for use when the device problem is not known) 83 83
Fracture 79 79
Material Frayed 78 78
Detachment Of Device Component 78 78
Material Deformation 77 77
Failure to Power Up 65 65
Inflation Problem 64 64
Unintended Movement 64 64
Positioning Problem 63 106
Device Contaminated During Manufacture or Shipping 60 60
Device Displays Incorrect Message 59 59
Peeled/Delaminated 55 55
Entrapment of Device 49 49
Fogging 48 48
Degraded 47 47
Connection Problem 45 45
Intermittent Energy Output 43 43
Mechanics Altered 42 42
Device Contamination with Chemical or Other Material 42 42
Self-Activation or Keying 42 42
Communication or Transmission Problem 41 41
Material Integrity Problem 41 41
Contamination /Decontamination Problem 38 38
Decrease in Pressure 37 37
Unintended Power Up 36 73
Power Problem 36 36
Unexpected Shutdown 36 36
Filling Problem 35 35
Particulates 35 35
Defective Component 35 35
Device Inoperable 35 35
Material Twisted/Bent 33 33
Optical Obstruction 32 32
Pumping Problem 30 30
Material Separation 29 29
Device Stops Intermittently 29 29
Loose or Intermittent Connection 28 28
Moisture Damage 28 28
Calibration Problem 28 28
Failure to Shut Off 28 28
Image Display Error/Artifact 27 27
Circuit Failure 27 27
Loss of or Failure to Bond 27 27
Unintended System Motion 26 26
Sticking 26 33
Fail-Safe Problem 26 26
Electrical Power Problem 25 25
Protective Measures Problem 25 25
Temperature Problem 23 23
Device Emits Odor 23 23
Delivered as Unsterile Product 22 22
Bent 22 22
Material Opacification 21 21
Insufficient Flow or Under Infusion 21 21
Thermal Decomposition of Device 20 20
Blocked Connection 20 20

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 2880 2963
No Known Impact Or Consequence To Patient 2332 2409
No Patient Involvement 1103 1240
Not Applicable 268 268
No Information 241 241
Insufficient Information 228 228
Extravasation 207 207
Foreign Body In Patient 200 200
No Code Available 137 137
Swelling 122 123
Device Embedded In Tissue or Plaque 108 108
Swelling/ Edema 96 96
Pain 75 75
Unspecified Infection 47 47
Bone Fracture(s) 44 44
Burn(s) 38 38
Injury 28 28
Unknown (for use when the patient's condition is not known) 26 26
Tissue Damage 24 24
Edema 23 23
Unspecified Tissue Injury 23 23
Joint Swelling 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Surgical procedure, delayed 14 14
Hematoma 14 14
Hemorrhage/Bleeding 11 11
Numbness 11 11
Inflammation 9 9
Laceration(s) 9 9
Pulmonary Embolism 9 9
Loss of Range of Motion 8 8
Abdominal Distention 8 8
Nerve Damage 7 7
Death 6 6
Post Operative Wound Infection 6 6
Burn, Thermal 5 5
Inadequate Pain Relief 5 5
Rupture 5 5
Discomfort 5 5
Neurological Deficit/Dysfunction 5 5
Paralysis 5 5
Overdose 5 5
Shock 4 4
Burning Sensation 4 4
Fever 4 4
Dyspnea 4 4
Complaint, Ill-Defined 4 4
Ambulation Difficulties 4 4
Patient Problem/Medical Problem 4 4
Full thickness (Third Degree) Burn 4 4
Blood Loss 3 3
Electric Shock 3 3
Collapse 3 3
Cerebrospinal Fluid Leakage 3 3
Exposure to Body Fluids 3 3
Neuropathy 3 3
Muscle Weakness 3 3
Muscular Rigidity 3 3
Infiltration into Tissue 3 3
Tingling 3 3
Dizziness 3 3
Failure of Implant 3 3
Pneumothorax 2 2
Skin Discoloration 2 2
Therapeutic Effects, Unexpected 2 2
Bacterial Infection 2 2
Cardiac Arrest 2 2
Adhesion(s) 2 2
Erythema 2 2
Arthralgia 2 2
Surgical procedure aborted/stopped 2 2
Spinal Cord Injury 2 2
Inadequate Osseointegration 2 2
Superficial (First Degree) Burn 2 2
Movement Disorder 2 2
Unspecified Nervous System Problem 1 1
Muscle/Tendon Damage 1 1
Fluid Discharge 1 1
Test Result 1 1
Limited Mobility Of The Implanted Joint 1 1
Alteration In Body Temperature 1 1
Chemical Exposure 1 1
Vascular System (Circulation), Impaired 1 1
Ascites 1 1
Neck Stiffness 1 1
Needle Stick/Puncture 1 1
Pallor 1 1
Cognitive Changes 1 1
Toxicity 1 1
Brain Injury 1 1
Discharge 1 1
Stenosis 1 1
Coma 1 1
Extubate 1 1
Malaise 1 1
Deformity/ Disfigurement 1 1
Non-union Bone Fracture 1 1
Joint Dislocation 1 1
Exsanguination 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ADRIA SRL II Oct-19-2021
2 Ascent Healthcare Solutions II Feb-03-2012
3 Biomet, Inc. II May-26-2016
4 Biomet, Inc. II Mar-07-2011
5 Customed, Inc II Sep-03-2015
6 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jan-15-2016
7 DePuy Mitek, Inc., a Johnson & Johnson Co. II Nov-08-2013
8 Instratek, Incorporated II Dec-22-2015
9 Linvatec Corp. dba ConMed Linvatec II Jul-10-2013
10 Linvatec Corp. dba ConMed Linvatec II Aug-24-2010
11 Linvatec Corp. dba ConMed Linvatec II Aug-09-2010
12 Linvatec Corp. dba ConMed Linvatec I Oct-01-2009
13 Medical Vision Ab II Aug-30-2016
14 Medtronic Sofamor Danek USA Inc II Jun-16-2020
15 Medtronic Spine LLC (formerly Kyphon Inc.) II Sep-09-2011
16 Medtronic Spine LLC, formerly Kyphon Inc II May-11-2009
17 MicroAire Surgical Instruments, LLC II Aug-08-2019
18 MicroAire Surgical Instruments, LLC II May-25-2018
19 Myelotec, Inc. II Jul-28-2017
20 ReNovo, Inc. II Mar-02-2021
21 Richard Wolf GmbH II Aug-22-2018
22 Richard Wolf Medical Instruments Corp. II Feb-09-2016
23 Smith & Nephew, Inc. II Jul-24-2020
24 Smith & Nephew, Inc. Endoscopy Division II Sep-21-2009
25 Stryker Endoscopy II Jun-25-2014
26 Stryker Endoscopy II Apr-08-2011
27 Stryker Endoscopy II Dec-28-2010
28 Stryker Endoscopy II Jan-21-2009
29 Stryker Endoscopy II Jan-16-2009
30 Stryker GmbH II Aug-28-2019
31 Stryker GmbH II Jun-20-2019
32 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
33 Stryker Instruments Div. of Stryker Corporation II Nov-01-2013
34 Stryker Instruments Division of Stryker Corporation II Mar-28-2011
35 Stryker Sustainability Solutions II Mar-05-2019
36 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
37 The Anspach Effort, Inc. II Jun-25-2014
38 Zimmer, Inc. II Apr-01-2013
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