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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, biopsy
Product CodeKNW
Regulation Number 876.1075
Device Class 2


Premarket Reviews
ManufacturerDecision
APRIOMED AB
  SUBSTANTIALLY EQUIVALENT 1
ARGON MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
AVITUS ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BARD PERIPHERAL VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIONCISE NV
  SUBSTANTIALLY EQUIVALENT 1
BIOPSYBELL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CANYON MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
DEVICOR MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GEOTEK MEDIKAL LTD STI
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU SHENGWEI MEDICAL DEVICES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ITP INNOVATIVE TOMOGRAPHY PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 2
LAURANE MEDICAL SAS
  SUBSTANTIALLY EQUIVALENT 1
MEDAX SRL UNIPERSONALE
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
NEODYNAMICS AB
  SUBSTANTIALLY EQUIVALENT 1
PRAXIS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
RANFAC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
REMINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU LEAPMED HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TEESUVAC APS
  SUBSTANTIALLY EQUIVALENT 1
TRANSMED7, LLC
  SUBSTANTIALLY EQUIVALENT 1
URAMIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
URO-1 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
URO-1, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 4195 4195
2020 5120 5120
2021 1020 1020
2022 535 535
2023 931 932
2024 869 869

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 4441 4441
Suction Problem 4411 4411
Failure to Obtain Sample 1489 1489
Self-Activation or Keying 473 473
Nonstandard Device 347 347
Adverse Event Without Identified Device or Use Problem 319 319
Difficult to Remove 313 313
Device Contamination with Chemical or Other Material 241 241
Leak/Splash 223 223
Break 187 187
Tear, Rip or Hole in Device Packaging 165 165
Material Twisted/Bent 158 158
Failure to Prime 153 153
Detachment of Device or Device Component 76 76
Device-Device Incompatibility 64 64
Firing Problem 64 64
Unintended Movement 62 62
Filling Problem 58 58
Device Difficult to Setup or Prepare 57 57
Mechanical Problem 51 51
Failure to Calibrate 49 49
Unsealed Device Packaging 41 41
Defective Device 40 40
Device Markings/Labelling Problem 40 40
Material Fragmentation 37 37
Therapeutic or Diagnostic Output Failure 36 36
Packaging Problem 30 30
Output Problem 29 29
Misfire 29 29
Material Deformation 28 28
Use of Device Problem 28 28
Suction Failure 27 27
Material Separation 25 25
Failure to Cycle 25 25
Fracture 23 23
Appropriate Term/Code Not Available 22 22
Improper or Incorrect Procedure or Method 20 20
Dull, Blunt 18 18
Accessory Incompatible 16 16
Physical Resistance/Sticking 16 16
Difficult to Open or Close 15 15
Product Quality Problem 14 14
Insufficient Information 14 14
Contamination 13 13
Component Misassembled 13 13
Mechanical Jam 13 13
Activation Problem 11 11
Premature Separation 11 11
Application Program Problem 10 10
Loose or Intermittent Connection 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6659 6659
No Clinical Signs, Symptoms or Conditions 3467 3468
No Patient Involvement 1477 1477
No Known Impact Or Consequence To Patient 396 396
Insufficient Information 156 156
Hemorrhage/Bleeding 108 108
Foreign Body In Patient 83 83
Hematoma 82 82
Pneumothorax 52 52
Needle Stick/Puncture 51 51
Pain 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
Device Embedded In Tissue or Plaque 25 25
Injury 17 17
Laceration(s) 16 16
Unspecified Infection 13 13
Breast Discomfort/Pain 10 10
Tissue Damage 9 9
Hemoptysis 9 9
Blood Loss 9 9
No Code Available 8 8
Hematuria 7 7
No Information 7 7
Unspecified Tissue Injury 6 6
Necrosis 6 6
Perforation 6 6
Syncope/Fainting 5 5
Discomfort 5 5
Air Embolism 4 4
Pseudoaneurysm 4 4
Chest Pain 4 4
Calcium Deposits/Calcification 3 3
Erythema 3 3
Device Overstimulation of Tissue 3 3
Pericardial Effusion 3 3
Intermenstrual Bleeding 3 3
Intraoperative Pain 3 3
Death 3 3
Superficial (First Degree) Burn 3 3
Hearing Impairment 3 3
Respiratory Insufficiency 2 2
Low Blood Pressure/ Hypotension 2 2
Exposure to Body Fluids 2 2
Bruise/Contusion 2 2
Nerve Damage 2 2
Electric Shock 2 2
Hemostasis 2 2
Skin Tears 2 2
Swelling/ Edema 2 2
Inadequate Pain Relief 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Sep-20-2024
2 Argon Medical Devices, Inc II Dec-09-2021
3 Argon Medical Devices, Inc II Jun-25-2020
4 Arrow International Inc II Apr-07-2021
5 Avitus Orthopaedics, Inc. II Mar-23-2019
6 BIOPSYBELL S.R.L. II May-19-2021
7 Bard Peripheral Vascular Inc II Jan-05-2024
8 Bard Peripheral Vascular Inc II Oct-04-2023
9 Bard Peripheral Vascular Inc II May-05-2023
10 Bard Peripheral Vascular Inc II Mar-16-2023
11 Bard Peripheral Vascular Inc II Oct-19-2021
12 Bard Peripheral Vascular Inc II Aug-12-2021
13 Bard Peripheral Vascular Inc II Mar-22-2021
14 Bard Peripheral Vascular Inc II Apr-09-2020
15 Bard Peripheral Vascular Inc II Mar-03-2020
16 Bard Peripheral Vascular Inc II Dec-20-2019
17 Bard Peripheral Vascular Inc II Aug-07-2019
18 Becton Dickinson & Company II Aug-28-2019
19 Hologic, Inc II Jun-29-2023
20 K2M, Inc II May-25-2019
21 M.D.L. S.r.l. II Sep-20-2021
22 Merit Medical Systems, Inc. II Oct-27-2022
23 Remington Medical, Inc. II Dec-28-2022
24 Zimmer Biomet, Inc. II Feb-04-2020
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