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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
CLARUS MEDICAL, LLC
  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
VERTOS 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 1610 1610

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1543 1544
Display or Visual Feedback Problem 707 707
Use of Device Problem 662 662
Electrical Shorting 639 639
Increase in Pressure 633 633
Poor Quality Image 522 522
Overheating of Device 473 509
Detachment of Device or Device Component 454 460
Electrical /Electronic Property Problem 437 437
Optical Problem 416 416
Material Rupture 387 387
Overfill 361 361
Device-Device Incompatibility 331 331
Improper Flow or Infusion 318 318
Pressure Problem 318 318
Crack 308 308
Infusion or Flow Problem 301 301
Leak/Splash 282 308
Appropriate Term/Code Not Available 250 250
Suction Failure 246 246
Output Problem 242 242
No Display/Image 227 227
Mechanical Jam 224 233
Mechanical Problem 218 218
Scratched Material 215 215
Material Disintegration 181 190
Defective Device 179 179
Excess Flow or Over-Infusion 164 164
Adverse Event Without Identified Device or Use Problem 164 164
Physical Resistance/Sticking 158 162
Fluid/Blood Leak 135 140
Device Operates Differently Than Expected 122 124
Device Remains Activated 117 122
Intermittent Loss of Power 111 111
Corroded 109 109
Noise, Audible 98 98
Material Deformation 97 97
Suction Problem 90 90
Intermittent Continuity 87 87
Material Frayed 85 85
Device Contaminated During Manufacture or Shipping 84 84
Material Fragmentation 80 84
Fracture 71 71
Insufficient Information 65 65
Failure to Power Up 65 65
Inflation Problem 63 63
Smoking 63 63
Positioning Problem 62 105
Unintended Movement 58 58
Peeled/Delaminated 53 53

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6646 6646
No Consequences Or Impact To Patient 2637 2709
No Known Impact Or Consequence To Patient 1645 1721
No Patient Involvement 603 697
Insufficient Information 274 274
Not Applicable 268 268
Foreign Body In Patient 183 183
Extravasation 159 159
No Information 144 144
Swelling/ Edema 116 116
No Code Available 71 71
Swelling 58 59
Device Embedded In Tissue or Plaque 52 52
Burn(s) 31 31
Pain 29 29
Unspecified Infection 28 28
Unspecified Tissue Injury 25 25
Injury 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Tissue Damage 18 18
Hematoma 16 16
Edema 13 13
Bone Fracture(s) 12 12
Hemorrhage/Bleeding 10 10
Inflammation 9 9
Laceration(s) 9 9
Loss of Range of Motion 7 7
Numbness 7 7
Cerebrospinal Fluid Leakage 6 6
Nerve Damage 6 6
Muscle Weakness 4 4
Rupture 4 4
Joint Swelling 4 4
Failure of Implant 3 3
Tingling 3 3
Dyspnea 3 3
Burn, Thermal 3 3
Electric Shock 3 3
Spinal Column Injury 3 3
Exposure to Body Fluids 3 3
Muscular Rigidity 3 3
Pulmonary Embolism 3 3
Paralysis 3 3
Burning Sensation 3 3
Patient Problem/Medical Problem 3 3
Discomfort 3 3
Shock 2 2
Bacterial Infection 2 2
Muscle/Tendon Damage 2 2
Infiltration into Tissue 2 2

Recalls
Manufacturer Recall Class Date Posted
1 ADRIA SRL II Oct-19-2021
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
3 Medtronic Sofamor Danek USA Inc II Jun-16-2020
4 MicroAire Surgical Instruments, LLC II Aug-08-2019
5 MicroAire Surgical Instruments, LLC II May-25-2018
6 Myelotec, Inc. II Jul-28-2017
7 ReNovo, Inc. II Mar-02-2021
8 Richard Wolf GmbH II Aug-22-2018
9 Smith & Nephew, Inc. II Jul-24-2020
10 Stryker GmbH II Aug-28-2019
11 Stryker GmbH II Jun-20-2019
12 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
13 Stryker Sustainability Solutions II Mar-05-2019
14 WOM World Of Medicine AG II Jul-01-2024
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