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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 1
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
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 319 319

Device Problems MDRs with this Device Problem Events in those MDRs
Suction Problem 4411 4411
Failure to Fire 4091 4091
Failure to Obtain Sample 1396 1396
Self-Activation or Keying 447 447
Nonstandard Device 336 336
Adverse Event Without Identified Device or Use Problem 298 298
Difficult to Remove 281 281
Leak/Splash 223 223
Device Contamination with Chemical or Other Material 220 220
Tear, Rip or Hole in Device Packaging 165 165
Break 161 161
Failure to Prime 139 139
Material Twisted/Bent 134 134
Device-Device Incompatibility 63 63
Detachment of Device or Device Component 59 59
Firing Problem 58 58
Filling Problem 58 58
Unintended Movement 56 56
Device Difficult to Setup or Prepare 53 53
Mechanical Problem 51 51
Failure to Calibrate 49 49
Defective Device 37 37
Material Fragmentation 37 37
Unsealed Device Packaging 37 37
Device Markings/Labelling Problem 36 36
Therapeutic or Diagnostic Output Failure 36 36
Output Problem 29 29
Misfire 29 29
Material Deformation 28 28
Packaging Problem 27 27
Use of Device Problem 27 27
Material Separation 25 25
Failure to Cycle 25 25
Suction Failure 24 24
Appropriate Term/Code Not Available 22 22
Fracture 20 20
Dull, Blunt 18 18
Physical Resistance/Sticking 16 16
Accessory Incompatible 16 16
Improper or Incorrect Procedure or Method 14 14
Product Quality Problem 14 14
Insufficient Information 14 14
Component Misassembled 13 13
Contamination 13 13
Mechanical Jam 13 13
Difficult to Open or Close 13 13
Activation Problem 11 11
Noise, Audible 10 10
Activation, Positioning or Separation Problem 10 10
Loose or Intermittent Connection 10 10
Premature Separation 10 10
Entrapment of Device 9 9
Retraction Problem 9 9
Device Misassembled During Manufacturing /Shipping 9 9
Separation Failure 9 9
Application Program Problem 8 8
Device Contaminated During Manufacture or Shipping 8 8
Activation Failure 8 8
Mechanics Altered 8 8
Device Damaged Prior to Use 8 8
Defective Component 7 7
Failure to Cut 7 7
Material Perforation 6 6
Fluid/Blood Leak 6 6
Computer Software Problem 6 6
Deformation Due to Compressive Stress 5 6
No Flow 5 5
No Apparent Adverse Event 4 4
Connection Problem 4 4
Difficult to Advance 4 4
Material Discolored 4 4
Crack 4 4
Difficult to Insert 4 4
No Device Output 4 4
Material Split, Cut or Torn 4 4
Missing Information 4 4
Device Slipped 3 3
Unstable 3 3
Shipping Damage or Problem 3 3
Fail-Safe Problem 3 3
Failure to Advance 3 3
Difficult or Delayed Activation 3 3
Migration 3 3
Separation Problem 2 2
Difficult or Delayed Separation 2 2
Positioning Problem 2 2
Protective Measures Problem 2 2
Scratched Material 2 2
Naturally Worn 2 2
No Fail-Safe Mechanism 2 2
Material Integrity Problem 2 2
Obstruction of Flow 2 2
Failure to Align 2 2
Device Displays Incorrect Message 2 2
Device Dislodged or Dislocated 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Component Missing 2 2
Inadequacy of Device Shape and/or Size 2 2
Fitting Problem 2 2
Overheating of Device 2 2

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 2975 2976
No Patient Involvement 1477 1477
No Known Impact Or Consequence To Patient 396 396
Insufficient Information 145 145
Hemorrhage/Bleeding 86 86
Hematoma 78 78
Foreign Body In Patient 78 78
Needle Stick/Puncture 48 48
Pneumothorax 45 45
Pain 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Device Embedded In Tissue or Plaque 23 23
Injury 17 17
Laceration(s) 15 15
Unspecified Infection 13 13
Breast Discomfort/Pain 10 10
Tissue Damage 9 9
Blood Loss 9 9
No Code Available 8 8
Hemoptysis 8 8
No Information 7 7
Hematuria 7 7
Necrosis 6 6
Unspecified Tissue Injury 6 6
Perforation 5 5
Discomfort 5 5
Syncope/Fainting 5 5
Chest Pain 4 4
Death 3 3
Erythema 3 3
Calcium Deposits/Calcification 3 3
Hearing Impairment 3 3
Pericardial Effusion 3 3
Intraoperative Pain 3 3
Intermenstrual Bleeding 3 3
Superficial (First Degree) Burn 3 3
Device Overstimulation of Tissue 3 3
Electric Shock 2 2
Nerve Damage 2 2
Hemostasis 2 2
Exposure to Body Fluids 2 2
Air Embolism 2 2
Respiratory Insufficiency 2 2
Swelling/ Edema 2 2
Hematemesis 1 1
Pancreatitis 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Unintended Radiation Exposure 1 1
Bacterial Infection 1 1
Abdominal Pain 1 1
Abscess 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Fever 1 1
Bone Fracture(s) 1 1
Cyst(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1
Internal Organ Perforation 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Perforation of Vessels 1 1
Pseudoaneurysm 1 1
Skin Tears 1 1
Inadequate Pain Relief 1 1
Reaction 1 1
Bronchopneumonia 1 1
Post Operative Wound Infection 1 1
Paraplegia 1 1
Diaphoresis 1 1
Sepsis 1 1
Sprain 1 1
Cardiac Tamponade 1 1
Distress 1 1
Fluid Discharge 1 1
Patient Problem/Medical Problem 1 1
Radiation Exposure, Unintended 1 1
Hyperesthesia 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Aspiration Pneumonitis 1 1
Cough 1 1

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