Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
CIT ORTHO
  SUBSTANTIALLY EQUIVALENT 1
CLARUS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
E SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EBERLE GMBH & CO. KG
  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
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
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
OK MEDINET KOREA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VERTOS MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
VISEON, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 1373 1373
Display or Visual Feedback Problem 705 705
Use of Device Problem 659 659
Increase in Pressure 544 544
Electrical Shorting 431 431
Detachment of Device or Device Component 421 421
Poor Quality Image 416 416
Optical Problem 415 415
Electrical /Electronic Property Problem 412 412
Overheating of Device 391 391
Device-Device Incompatibility 324 324
Improper Flow or Infusion 314 314
Infusion or Flow Problem 299 299
Crack 297 297
Pressure Problem 261 261
Output Problem 242 242
Leak/Splash 224 224
Material Rupture 223 223
Overfill 221 221
Appropriate Term/Code Not Available 214 214
Scratched Material 196 196
Mechanical Jam 193 193
Mechanical Problem 193 193
Defective Device 179 179
Suction Failure 176 176
Physical Resistance/Sticking 150 150
Excess Flow or Over-Infusion 135 135
Material Disintegration 132 132
Adverse Event Without Identified Device or Use Problem 116 116
No Display/Image 110 110
Corroded 105 105
Device Remains Activated 103 103
Material Deformation 97 97
Fluid/Blood Leak 89 89
Noise, Audible 88 88
Device Contaminated During Manufacture or Shipping 84 84
Material Frayed 84 84
Fracture 68 68
Intermittent Loss of Power 66 66
Intermittent Continuity 64 64
Inflation Problem 59 59
Insufficient Information 55 55
Entrapment of Device 48 48
Degraded 48 48
Unintended Movement 47 47
Connection Problem 47 47
Contamination /Decontamination Problem 44 44
Material Integrity Problem 44 44
Mechanics Altered 44 44
Material Fragmentation 44 44

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6645 6645
No Consequences Or Impact To Patient 1624 1624
No Known Impact Or Consequence To Patient 592 592
No Patient Involvement 421 421
Insufficient Information 274 274
Not Applicable 221 221
Foreign Body In Patient 137 137
Extravasation 136 136
Swelling/ Edema 116 116
No Code Available 44 44
Swelling 39 39
No Information 35 35
Unspecified Tissue Injury 25 25
Burn(s) 25 25
Unspecified Infection 22 22
Device Embedded In Tissue or Plaque 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Pain 19 19
Hematoma 15 15
Injury 14 14
Hemorrhage/Bleeding 10 10
Tissue Damage 9 9
Laceration(s) 9 9
Inflammation 9 9
Bone Fracture(s) 9 9
Edema 8 8
Loss of Range of Motion 7 7
Cerebrospinal Fluid Leakage 6 6
Nerve Damage 6 6
Numbness 6 6
Muscle Weakness 4 4
Rupture 3 3
Patient Problem/Medical Problem 3 3
Burning Sensation 3 3
Tingling 3 3
Exposure to Body Fluids 3 3
Muscular Rigidity 3 3
Joint Swelling 3 3
Neuropathy 2 2
Pulmonary Embolism 2 2
Spinal Cord Injury 2 2
Superficial (First Degree) Burn 2 2
Infiltration into Tissue 2 2
Bacterial Infection 2 2
Pneumothorax 2 2
Shock 2 2
Muscle/Tendon Damage 2 2
Failure of Implant 2 2
Discomfort 2 2
Inadequate Osseointegration 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 ReNovo, Inc. II Mar-02-2021
6 Smith & Nephew, Inc. II Jul-24-2020
7 Stryker GmbH II Aug-28-2019
8 Stryker GmbH II Jun-20-2019
9 Stryker Sustainability Solutions II Mar-05-2019
10 WOM World Of Medicine AG II Jul-01-2024
-
-