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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
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
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
VERTOS 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 1407 1407
2023 1853 1853
2024 1610 1610

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1475 1475
Display or Visual Feedback Problem 706 706
Use of Device Problem 660 660
Increase in Pressure 616 616
Electrical Shorting 577 577
Detachment of Device or Device Component 454 460
Poor Quality Image 449 449
Overheating of Device 432 448
Electrical /Electronic Property Problem 425 425
Optical Problem 416 416
Overfill 357 357
Device-Device Incompatibility 331 331
Improper Flow or Infusion 316 316
Pressure Problem 303 303
Crack 303 303
Infusion or Flow Problem 300 300
Material Rupture 294 294
Leak/Splash 250 267
Suction Failure 242 242
Output Problem 242 242
Appropriate Term/Code Not Available 232 232
Mechanical Jam 222 231
Mechanical Problem 217 217
Scratched Material 208 208
Defective Device 179 179
Material Disintegration 179 188
Physical Resistance/Sticking 158 162
Excess Flow or Over-Infusion 154 154
No Display/Image 137 137
Fluid/Blood Leak 133 138
Adverse Event Without Identified Device or Use Problem 130 130
Device Remains Activated 111 113
Intermittent Loss of Power 110 110
Corroded 109 109
Material Deformation 97 97
Noise, Audible 93 93
Intermittent Continuity 86 86
Material Frayed 84 84
Device Contaminated During Manufacture or Shipping 84 84
Suction Problem 73 73
Fracture 68 68
Failure to Power Up 64 64
Inflation Problem 63 63
Positioning Problem 60 78
Material Fragmentation 60 64
Unintended Movement 58 58
Insufficient Information 55 55
Peeled/Delaminated 53 53
Smoking 51 51
Entrapment of Device 48 48

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 2533 2551
No Known Impact Or Consequence To Patient 1064 1116
No Patient Involvement 544 587
Insufficient Information 274 274
Not Applicable 266 266
Foreign Body In Patient 165 165
Extravasation 149 149
Swelling/ Edema 116 116
No Code Available 52 52
No Information 43 43
Swelling 42 43
Device Embedded In Tissue or Plaque 32 32
Burn(s) 29 29
Unspecified Tissue Injury 25 25
Unspecified Infection 23 23
Pain 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Hematoma 16 16
Injury 15 15
Tissue Damage 11 11
Bone Fracture(s) 11 11
Hemorrhage/Bleeding 10 10
Edema 10 10
Inflammation 9 9
Laceration(s) 9 9
Loss of Range of Motion 7 7
Nerve Damage 6 6
Cerebrospinal Fluid Leakage 6 6
Numbness 6 6
Rupture 4 4
Muscle Weakness 4 4
Burn, Thermal 3 3
Dyspnea 3 3
Joint Swelling 3 3
Burning Sensation 3 3
Tingling 3 3
Patient Problem/Medical Problem 3 3
Exposure to Body Fluids 3 3
Muscular Rigidity 3 3
Muscle/Tendon Damage 2 2
Shock 2 2
Discomfort 2 2
Bacterial Infection 2 2
Infiltration into Tissue 2 2
Spinal Cord Injury 2 2
Pulmonary Embolism 2 2
Movement Disorder 2 2
Spinal Column Injury 2 2
Adhesion(s) 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 ReNovo, Inc. II Mar-02-2021
7 Richard Wolf GmbH II Aug-22-2018
8 Smith & Nephew, Inc. II Jul-24-2020
9 Stryker GmbH II Aug-28-2019
10 Stryker GmbH II Jun-20-2019
11 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
12 Stryker Sustainability Solutions II Mar-05-2019
13 WOM World Of Medicine AG II Jul-01-2024
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