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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device biopsy needle
Product CodeFCG
Regulation Number 876.1075
Device Class 2


Premarket Reviews
ManufacturerDecision
APRIOMED AB
  SUBSTANTIALLY EQUIVALENT 1
BEACON ENDOSCOPIC
  SUBSTANTIALLY EQUIVALENT 1
BIBBINSTRUMENTS AB
  SUBSTANTIALLY EQUIVALENT 1
BOSTON ENDOSCOPIC ENGINEERING
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CHANGZHOU DETAIN MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 3
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 3
CORBIN CLINICAL RESOURCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP)
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC( FORMERLY BEACON ENDOSCOPIC CORP.)
  SUBSTANTIALLY EQUIVALENT 1
FINEMEDIX CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
FINEMEDIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
H.S. HOSPITAL SERVICES S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
LIMACA MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
MEDI-GLOBE CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 5
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU LEAPMED HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES ENDOSCOPY GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
USHARE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 154 154
2015 124 124
2016 190 190
2017 273 273
2018 282 282
2019 229 229
2020 240 240
2021 289 289
2022 304 304
2023 430 430
2024 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Break 721 721
Fracture 282 282
Adverse Event Without Identified Device or Use Problem 214 214
Material Twisted/Bent 210 210
Retraction Problem 208 208
Improper or Incorrect Procedure or Method 131 131
Bent 123 123
Off-Label Use 114 114
Occlusion Within Device 106 106
Detachment of Device or Device Component 86 86
Physical Resistance/Sticking 84 84
Kinked 71 71
Difficult to Remove 71 71
Material Perforation 51 51
Material Separation 50 50
Material Deformation 42 42
Difficult to Advance 35 35
Use of Device Problem 34 34
Device Contamination with Chemical or Other Material 33 33
Detachment Of Device Component 32 32
Mechanical Problem 31 31
Material Puncture/Hole 25 25
Insufficient Information 24 24
Failure to Advance 23 23
Tear, Rip or Hole in Device Packaging 23 23
Device Damaged Prior to Use 21 21
Material Fragmentation 20 20
Device-Device Incompatibility 17 17
Device Markings/Labelling Problem 16 16
Failure to Obtain Sample 16 16
Device Operates Differently Than Expected 16 16
Activation, Positioning or Separation Problem 15 15
No Apparent Adverse Event 14 14
Device Fell 12 12
Difficult to Insert 12 12
Defective Device 11 11
Dent in Material 10 10
Tip breakage 9 9
Entrapment of Device 9 9
Material Split, Cut or Torn 9 9
Positioning Problem 9 9
Output Problem 8 8
Structural Problem 8 8
Mechanical Jam 8 8
Positioning Failure 8 8
Device Slipped 8 8
Defective Component 7 7
Unsealed Device Packaging 7 7
Leak/Splash 6 6
Loose or Intermittent Connection 6 6
Loss of or Failure to Bond 6 6
Component Missing 6 6
Device Contaminated During Manufacture or Shipping 6 6
Misfire 6 6
Device Operational Issue 6 6
Packaging Problem 6 6
Failure to Eject 6 6
Appropriate Term/Code Not Available 6 6
Material Protrusion/Extrusion 5 5
Separation Problem 5 5
Device Damaged by Another Device 5 5
Failure to Fire 5 5
Difficult to Open or Close 5 5
Needle, separation 5 5
No Display/Image 4 4
Contamination 4 4
Material Frayed 4 4
Sticking 4 4
Fitting Problem 4 4
Device Dislodged or Dislocated 4 4
Material Integrity Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Physical Property Issue 3 3
Expiration Date Error 3 3
Dull, Blunt 3 3
Device Inoperable 3 3
Shipping Damage or Problem 3 3
Material Too Rigid or Stiff 3 3
Disconnection 3 3
Component Falling 3 3
Peeled/Delaminated 3 3
Needle, unsheathed 2 2
Nonstandard Device 2 2
Display or Visual Feedback Problem 2 2
Accessory Incompatible 2 2
Crack 2 2
Unraveled Material 2 2
Premature Activation 2 2
Device Issue 2 2
Activation Problem 2 2
Migration 2 2
Device Or Device Fragments Location Unknown 2 2
Split 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Difficult or Delayed Activation 1 1
Physical Resistance 1 1
Wrinkled 1 1
Malposition of Device 1 1
Aspiration Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 786 786
No Known Impact Or Consequence To Patient 634 634
No Consequences Or Impact To Patient 566 566
Foreign Body In Patient 279 279
Hemorrhage/Bleeding 65 65
No Patient Involvement 47 47
Device Embedded In Tissue or Plaque 45 45
Insufficient Information 39 39
No Code Available 31 31
Gastrointestinal Hemorrhage 26 26
Pneumothorax 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Pain 21 21
Abdominal Pain 18 18
No Information 18 18
Pancreatitis 18 18
Inflammation 16 16
Needle Stick/Puncture 15 15
Unspecified Infection 14 14
Fever 14 14
Hematoma 13 13
Injury 13 13
Blood Loss 13 13
Peritonitis 12 12
Death 11 11
Abscess 11 11
Perforation 10 10
Foreign body, removal of 9 9
Pneumonia 7 7
Hypoxia 6 6
Unspecified Hepatic or Biliary Problem 6 6
Unspecified Tissue Injury 6 6
Radiation Exposure, Unintended 5 5
Low Blood Pressure/ Hypotension 5 5
Hemoptysis 5 5
Sepsis 5 5
Septic Shock 4 4
Respiratory Failure 4 4
Dyspnea 4 4
Bleeding 4 4
Thrombocytopenia 4 4
Cough 4 4
Cancer 3 3
Fibrosis 3 3
Unspecified Gastrointestinal Problem 3 3
Exposure to Body Fluids 3 3
Biliary Cirrhosis 3 3
Cardiac Arrest 3 3
Hemostasis 3 3
Confusion/ Disorientation 3 3
Internal Organ Perforation 3 3
Vomiting 3 3
Discomfort 2 2
Transfusion of blood products 2 2
Nausea 2 2
Surgical procedure, additional 2 2
Respiratory Tract Infection 2 2
Obstruction/Occlusion 2 2
Hemothorax 2 2
Pulmonary Emphysema 2 2
Cyst(s) 2 2
Cardiopulmonary Arrest 2 2
Bradycardia 2 2
Air Embolism 2 2
Wheezing 2 2
Not Applicable 2 2
Bronchospasm 2 2
Perforation of Vessels 2 2
Patient Problem/Medical Problem 1 1
Pseudoaneurysm 1 1
Low Oxygen Saturation 1 1
Syncope/Fainting 1 1
Pleural Empyema 1 1
Unspecified Respiratory Problem 1 1
Muscle Hypotonia 1 1
Cancer Cells Dissemination 1 1
Localized Skin Lesion 1 1
Abrasion 1 1
Vessel Or Plaque, Device Embedded In 1 1
Chest Pain 1 1
Dysphagia/ Odynophagia 1 1
Fistula 1 1
Granuloma 1 1
Headache 1 1
Laceration(s) 1 1
Liver Damage/Dysfunction 1 1
Liver Laceration(s) 1 1
Muscle Weakness 1 1
Extravasation 1 1
Hepatitis 1 1
Respiratory Distress 1 1
Sedation 1 1
Sore Throat 1 1
Hospitalization required 1 1
Ascites 1 1
Decreased Respiratory Rate 1 1
Sleep Dysfunction 1 1
Therapy/non-surgical treatment, additional 1 1
Strangulation 1 1
Suffocation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Bard Peripheral Vascular Inc II Oct-02-2018
3 Bard Peripheral Vascular Inc II Aug-16-2016
4 Bard Peripheral Vascular Inc II Nov-17-2009
5 Boston Scientific Corp III Jan-12-2009
6 Boston Scientific Corporation III Sep-16-2011
7 Boston Scientific Corporation II Dec-27-2010
8 Cardinal Health II Nov-09-2009
9 Cook Inc. II Aug-22-2016
10 Covidien Llc II Aug-05-2020
11 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
12 Medtronic II Feb-28-2017
13 Olympus America Inc. II Oct-07-2011
14 Olympus Corporation of the Americas III May-19-2023
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