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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
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 2
BIOPSYBELL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CANYON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARBON (SHENZHEN) MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEVICOR MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FORCYTE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
GEOTEK MEDIKAL LTD STI
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU SHENGWEI MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
H.S HOSPITAL SERVICE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
INRAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
ITP INNOVATIVE TOMOGRAPHY PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 2
LAURANE MEDICAL SAS
  SUBSTANTIALLY EQUIVALENT 1
NEODYNAMICS AB
  SUBSTANTIALLY EQUIVALENT 1
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
RANFAC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RESITU MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU LEAPMED HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
TEESUVAC APS
  SUBSTANTIALLY EQUIVALENT 1
TRIOPSY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
URAMIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
URO-1 MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
URO-1, INC.
  SUBSTANTIALLY EQUIVALENT 2
XAGA SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 1020 1023
2022 535 540
2023 931 937
2024 1283 1286
2025 1694 1694

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Fire 2371 2371
Failure to Obtain Sample 830 830
Adverse Event Without Identified Device or Use Problem 352 353
Self-Activation or Keying 343 343
Difficult to Remove 297 297
Break 234 239
Material Twisted/Bent 204 206
Device Contamination with Chemical or Other Material 191 191
Tear, Rip or Hole in Device Packaging 176 176
Failure to Prime 128 128
Detachment of Device or Device Component 98 99
Device Markings/Labelling Problem 80 84
Unintended Movement 76 76
Firing Problem 71 71
Material Fragmentation 70 70
Device-Device Incompatibility 66 66
Device Difficult to Setup or Prepare 58 58
Mechanical Problem 55 55
Suction Problem 55 55
Contamination 40 40
Activation, Positioning or Separation Problem 39 39
Packaging Problem 36 36
Misfire 36 38
Improper or Incorrect Procedure or Method 33 33
Fluid/Blood Leak 31 31
Material Separation 31 34
Defective Device 29 29
Positioning Problem 29 29
Application Program Problem 29 29
Use of Device Problem 28 28
Nonstandard Device 28 28
Product Quality Problem 27 27
Therapeutic or Diagnostic Output Failure 26 26
Fracture 26 26
Material Deformation 24 24
Unsealed Device Packaging 23 23
Insufficient Information 21 21
Suction Failure 21 21
Dull, Blunt 19 19
Illegible Information 17 17
Difficult to Insert 17 17
Output Problem 17 18
Patient Device Interaction Problem 16 16
Mechanical Jam 16 17
Failure to Cycle 15 15
Filling Problem 14 14
Crack 14 14
Physical Resistance/Sticking 14 14
Activation Failure 14 14
Noise, Audible 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4716 4725
Insufficient Information 180 190
Hemorrhage/Bleeding 148 149
Foreign Body In Patient 106 106
Hematoma 90 90
Pneumothorax 62 62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 51 51
Needle Stick/Puncture 49 49
Pain 46 46
Laceration(s) 17 17
Device Embedded In Tissue or Plaque 15 15
Breast Discomfort/Pain 14 14
Hemoptysis 13 13
Perforation 8 8
Air Embolism 7 7
Unspecified Tissue Injury 7 7
Syncope/Fainting 6 6
Necrosis 6 6
Discomfort 6 6
Hematuria 5 5
Swelling/ Edema 5 5
Unspecified Infection 4 4
Bacterial Infection 4 4
Pseudoaneurysm 4 4
Fever 4 4
Chest Pain 4 4
Intraoperative Pain 3 3
Low Blood Pressure/ Hypotension 3 3
No Consequences Or Impact To Patient 3 3
Erythema 3 3
Bruise/Contusion 2 2
Respiratory Insufficiency 2 2
Skin Tears 2 2
Perforation of Vessels 2 2
Calcium Deposits/Calcification 2 2
Abscess 2 2
Urinary Retention 2 2
Nerve Damage 2 2
Hypersensitivity/Allergic reaction 2 2
Sepsis 2 2
Cardiac Arrest 2 2
Inflammation 2 2
Pericardial Effusion 2 2
Unintended Radiation Exposure 1 1
Aspiration Pneumonitis 1 1
Bronchopneumonia 1 1
Distress 1 1
Urinary Tract Infection 1 1
Stroke/CVA 1 1
Pancreatitis 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 Arrow International Inc II Apr-07-2021
4 BIOPSYBELL S.R.L. II May-19-2021
5 Bard Peripheral Vascular Inc II Nov-15-2024
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 Hologic, Inc II Feb-13-2025
14 Hologic, Inc II Jun-29-2023
15 M.D.L. S.r.l. II Sep-20-2021
16 Merit Medical Systems, Inc. II Oct-27-2022
17 Remington Medical, Inc. II Dec-28-2022
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