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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biopsy needle
Regulation Description Gastroenterology-urology biopsy instrument.
Product CodeFCG
Regulation Number 876.1075
Device Class 2


Premarket Reviews
ManufacturerDecision
BIBBINSTRUMENTS AB
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 3
FINEMEDIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIMACA MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU LEAPMED HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
USHARE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 240 240
2021 289 289
2022 304 304
2023 431 431
2024 446 446
2025 264 264

Device Problems MDRs with this Device Problem Events in those MDRs
Break 485 485
Fracture 297 297
Material Twisted/Bent 262 262
Improper or Incorrect Procedure or Method 185 185
Adverse Event Without Identified Device or Use Problem 181 181
Off-Label Use 154 154
Detachment of Device or Device Component 114 114
Retraction Problem 105 105
Physical Resistance/Sticking 95 95
Material Separation 48 48
Use of Device Problem 44 44
Difficult to Remove 44 44
Material Perforation 42 42
Mechanical Problem 36 36
Material Split, Cut or Torn 27 27
Device Damaged Prior to Use 25 25
Difficult to Advance 25 25
Device Contamination with Chemical or Other Material 24 24
Dent in Material 21 21
Insufficient Information 21 21
Failure to Obtain Sample 20 20
Device-Device Incompatibility 18 18
Difficult to Open or Close 17 17
Material Fragmentation 16 16
Failure to Advance 16 16
Material Puncture/Hole 16 16
Difficult to Insert 13 13
Material Deformation 11 11
Structural Problem 11 11
Device Markings/Labelling Problem 10 10
No Apparent Adverse Event 10 10
Device Fell 9 9
Loss of or Failure to Bond 9 9
Mechanical Jam 8 8
Positioning Problem 7 7
Defective Device 7 7
Contamination 7 7
Output Problem 6 6
Unintended Movement 6 6
Failure to Eject 6 6
Material Integrity Problem 5 5
Material Protrusion/Extrusion 5 5
Leak/Splash 5 5
Dull, Blunt 5 5
Tear, Rip or Hole in Device Packaging 5 5
Component Missing 5 5
Separation Problem 5 5
Unstable 5 5
Device Slipped 5 5
Positioning Failure 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1343 1343
Foreign Body In Patient 211 211
No Consequences Or Impact To Patient 125 125
Hemorrhage/Bleeding 89 89
No Known Impact Or Consequence To Patient 76 76
Insufficient Information 54 54
Pancreatitis 38 38
Gastrointestinal Hemorrhage 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Abdominal Pain 21 21
Fever 20 20
Peritonitis 18 18
Pneumothorax 18 18
Pain 16 16
Device Embedded In Tissue or Plaque 15 15
Unspecified Infection 15 15
No Patient Involvement 14 14
Hematoma 12 12
Perforation 11 11
Unspecified Hepatic or Biliary Problem 9 9
Inflammation 9 9
No Code Available 8 8
Low Blood Pressure/ Hypotension 8 8
Abscess 7 7
Needle Stick/Puncture 7 7
Unspecified Tissue Injury 6 6
Pneumonia 6 6
Hypoxia 6 6
Air Embolism 5 5
Injury 5 5
Sepsis 5 5
Respiratory Failure 5 5
Cough 4 4
Thrombocytopenia 4 4
Low Oxygen Saturation 4 4
Blood Loss 4 4
Hemoptysis 4 4
Biliary Cirrhosis 4 4
Fibrosis 3 3
Obstruction/Occlusion 3 3
Dyspnea 3 3
Septic Shock 3 3
Death 3 3
Vomiting 3 3
Cardiac Arrest 3 3
Unspecified Gastrointestinal Problem 3 3
Confusion/ Disorientation 2 2
Laceration(s) 2 2
Nausea 2 2
Respiratory Tract Infection 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Bard Peripheral Vascular Inc II Sep-20-2024
3 Cook Medical Incorporated II May-16-2024
4 Covidien Llc II Aug-05-2020
5 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
6 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
7 Olympus Corporation of the Americas III May-19-2023
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