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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
APRIOMED AB
  SUBSTANTIALLY EQUIVALENT 1
COOK (CANADA), INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORBIN CLINICAL RESOURCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 4
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 190 190
2017 273 273
2018 282 282
2019 229 229
2020 240 240
2021 107 107

Device Problems MDRs with this Device Problem Events in those MDRs
Break 435 435
Retraction Problem 105 105
Fracture 92 92
Bent 90 90
Material Twisted/Bent 88 88
Occlusion Within Device 86 86
Adverse Event Without Identified Device or Use Problem 81 81
Kinked 67 67
Off-Label Use 49 49
Improper or Incorrect Procedure or Method 43 43
Material Deformation 40 40
Difficult to Remove 36 36
Material Separation 32 32
Material Perforation 28 28
Detachment of Device or Device Component 28 28
Physical Resistance/Sticking 22 22
Tear, Rip or Hole in Device Packaging 20 20
Detachment Of Device Component 19 19
Failure to Advance 15 15
Insufficient Information 15 15
Difficult to Advance 13 13
Activation, Positioning or SeparationProblem 12 12
Device Operates Differently Than Expected 9 9
Device Contamination with Chemical or Other Material 9 9
Use of Device Problem 8 8
Material Fragmentation 8 8
Material Puncture/Hole 7 7
No Apparent Adverse Event 7 7
Device Markings/Labelling Problem 7 7
Device Fell 6 6
Appropriate Term/Code Not Available 6 6
Packaging Problem 6 6
Unsealed Device Packaging 6 6
Mechanical Problem 6 6
Device Slipped 6 6
Device Operational Issue 6 6
Defective Device 5 5
Failure to Obtain Sample 5 5
Defective Component 5 5
Failure to Fire 5 5
Difficult to Insert 5 5
Entrapment of Device 4 4
Device Damaged Prior to Use 4 4
Positioning Problem 4 4
Device Damaged by Another Device 4 4
Mechanical Jam 4 4
Physical Property Issue 3 3
Device Dislodged or Dislocated 3 3
Loss of or Failure to Bond 3 3
Positioning Failure 3 3
Material Too Rigid or Stiff 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Component Falling 3 3
Disconnection 3 3
Loose or Intermittent Connection 3 3
Peeled/Delaminated 2 2
Contamination 2 2
Sticking 2 2
Device Inoperable 2 2
Misfire 2 2
Device-Device Incompatibility 2 2
Shipping Damage or Problem 2 2
Device Or Device Fragments Location Unknown 2 2
Device Issue 2 2
Material Protrusion/Extrusion 2 2
Difficult to Open or Close 2 2
Output Problem 2 2
Activation Problem 2 2
Separation Problem 1 1
Unclear Information 1 1
Device Handling Problem 1 1
Material Split, Cut or Torn 1 1
Protective Measures Problem 1 1
Obstruction of Flow 1 1
Expiration Date Error 1 1
Out-Of-Box Failure 1 1
Stretched 1 1
Wrinkled 1 1
Delivery System Failure 1 1
Device Packaging Compromised 1 1
Failure to Prime 1 1
Fluid Leak 1 1
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
Material Integrity Problem 1 1
Unintended Movement 1 1
Activation Failure 1 1
Dull, Blunt 1 1
Malfunction 1 1
Failure to Disconnect 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Contaminated During Manufacture or Shipping 1 1
Accessory Incompatible 1 1
Fail-Safe Design Failure 1 1
Flaked 1 1
Material Frayed 1 1
Product Quality Problem 1 1
Failure to Transmit Record 1 1
Failure to Reset 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 519 519
No Consequences Or Impact To Patient 461 461
Foreign Body In Patient 143 143
No Clinical Signs, Symptoms or Conditions 64 64
No Patient Involvement 43 43
Device Embedded In Tissue or Plaque 30 30
No Code Available 28 28
Hemorrhage/Bleeding 25 25
Injury 12 12
Needle Stick/Puncture 12 12
Blood Loss 12 12
Pain 11 11
Inflammation 11 11
Pneumothorax 8 8
No Information 8 8
Death 7 7
Abdominal Pain 7 7
Unspecified Infection 6 6
Radiation Exposure, Unintended 5 5
Abscess 5 5
Perforation 4 4
Fever 3 3
Exposure to Body Fluids 3 3
Hemostasis 3 3
Hemoptysis 2 2
Not Applicable 2 2
Cardiac Arrest 2 2
Hematoma 2 2
Low Blood Pressure/ Hypotension 2 2
Peritonitis 2 2
Cancer 2 2
Pancreatitis 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Sedation 1 1
Vessel Or Plaque, Device Embedded In 1 1
Mediastinal Shift 1 1
Hepatitis 1 1
Pulmonary Emphysema 1 1
Patient Problem/Medical Problem 1 1
Gastrointestinal Hemorrhage 1 1
Bradycardia 1 1
Biliary Cirrhosis 1 1
Liver Damage/Dysfunction 1 1
Internal Organ Perforation 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Ascites 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 Cook Inc. II Aug-22-2016
5 Covidien Llc II Aug-05-2020
6 Medtronic II Feb-28-2017
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