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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clip, implantable
Regulation Description Implantable clip.
Product CodeFZP
Regulation Number 878.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMSEL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 6
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 1
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANOVA BIOMATERIALS INC
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VESOCCLUDE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1840 1840
2017 2594 2594
2018 2718 2718
2019 2903 2955
2020 1760 1760
2021 420 420

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Form Staple 2385 2437
Mechanics Altered 1659 1659
Difficult to Open or Close 1383 1383
Mechanical Jam 1031 1031
Misfire 1016 1016
Mechanical Problem 938 938
Break 898 898
Activation, Positioning or SeparationProblem 759 759
Failure to Fire 494 494
Failure To Adhere Or Bond 468 468
Detachment of Device or Device Component 341 341
Material Deformation 325 325
Device Operates Differently Than Expected 316 316
Device Slipped 235 235
Unintended Ejection 198 198
Adverse Event Without Identified Device or Use Problem 165 165
Firing Problem 161 161
Failure to Advance 159 159
Premature Activation 153 153
Device Fell 149 149
Detachment Of Device Component 137 137
Positioning Failure 128 128
Loss of or Failure to Bond 125 125
Failure to Align 118 118
Component Falling 105 105
Entrapment of Device 88 88
Fail-Safe Problem 71 71
Display or Visual Feedback Problem 68 68
Device Dislodged or Dislocated 59 59
Physical Resistance/Sticking 58 58
Sticking 55 55
Difficult to Remove 54 54
Material Twisted/Bent 51 51
Unintended Movement 50 50
Material Fragmentation 49 49
Insufficient Information 48 48
Defective Device 46 46
Loose or Intermittent Connection 44 44
Noise, Audible 43 43
Positioning Problem 42 42
Device Inoperable 40 40
Material Integrity Problem 37 37
Leak/Splash 36 36
Tear, Rip or Hole in Device Packaging 34 34
Appropriate Term/Code Not Available 33 33
Component Missing 33 33
Defective Component 31 31
Difficult or Delayed Positioning 27 27
Separation Failure 27 27
Physical Resistance 25 25
Bent 23 23
Migration or Expulsion of Device 20 20
Premature Separation 20 20
Use of Device Problem 19 19
Fracture 18 18
Material Separation 17 17
Material Protrusion/Extrusion 16 16
Product Quality Problem 16 16
Activation Failure 15 15
Unsealed Device Packaging 15 15
Patient-Device Incompatibility 14 14
Improper or Incorrect Procedure or Method 14 14
Therapeutic or Diagnostic Output Failure 13 13
No Apparent Adverse Event 13 13
Material Puncture/Hole 12 12
Delivered as Unsterile Product 12 12
Image Display Error/Artifact 11 11
Fluid Leak 11 11
Activation Problem 11 11
Crack 10 10
Expiration Date Error 10 10
Difficult to Insert 10 10
Device Contamination with Chemical or Other Material 10 10
Compatibility Problem 9 9
Malposition of Device 9 9
Split 9 9
Device Packaging Compromised 9 9
Device Damaged by Another Device 8 8
Difficult To Position 8 8
Ejection Problem 8 8
Device Displays Incorrect Message 8 8
Difficult to Advance 8 8
Partial Blockage 8 8
Packaging Problem 7 7
Separation Problem 7 7
Expulsion 7 7
Component or Accessory Incompatibility 6 6
Retraction Problem 6 6
Hole In Material 6 6
Patient Device Interaction Problem 6 6
Torn Material 6 6
Device Handling Problem 5 5
Material Split, Cut or Torn 5 5
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 5 5
Precipitate in Device or Device Ingredient 5 5
Material Too Rigid or Stiff 4 4
Fitting Problem 4 4
Device Damaged Prior to Use 4 4
Device Markings/Labelling Problem 4 4
Chemical Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8473 8525
No Known Impact Or Consequence To Patient 2159 2159
No Clinical Signs, Symptoms or Conditions 683 683
No Code Available 316 316
No Information 254 254
Blood Loss 162 162
No Patient Involvement 156 156
Tissue Damage 148 148
Insufficient Information 57 57
Hemorrhage/Bleeding 52 52
Foreign Body In Patient 46 46
Injury 45 45
Perforation of Vessels 40 40
Failure to Anastomose 29 29
Not Applicable 29 29
Pain 25 25
Device Embedded In Tissue or Plaque 23 23
Perforation 23 23
Death 19 19
Extravasation 16 16
Unspecified Infection 14 14
Inflammation 13 13
Radiation Exposure, Unintended 12 12
Thrombus 11 11
Hematoma 11 11
Patient Problem/Medical Problem 10 10
Fistula 9 9
Laceration(s) 8 8
Unspecified Tissue Injury 8 8
Abdominal Pain 7 7
Hypersensitivity/Allergic reaction 6 6
Wound Dehiscence 6 6
Peritonitis 6 6
Abscess 5 5
Failure of Implant 5 5
Hemostasis 5 5
Sepsis 4 4
Fever 4 4
Fluid Discharge 4 4
Low Blood Pressure/ Hypotension 3 3
Anemia 3 3
Fatigue 3 3
Cardiac Arrest 3 3
Stenosis 3 3
Reaction 3 3
Obstruction/Occlusion 2 2
Post Operative Wound Infection 2 2
Scar Tissue 2 2
Seroma 2 2
Nerve Damage 2 2
Urticaria 2 2
Stroke/CVA 2 2
Erythema 2 2
Exsanguination 2 2
Renal Failure 2 2
Unspecified Heart Problem 2 2
Unintended Radiation Exposure 2 2
Abdominal Distention 2 2
Bowel Perforation 1 1
Vitreous Hemorrhage 1 1
Multiple Organ Failure 1 1
Pericardial Effusion 1 1
Suicidal Ideation 1 1
Shock, Postoperative 1 1
Loss of consciousness 1 1
Atrial Perforation 1 1
Skin Tears 1 1
Ambulation Difficulties 1 1
Rupture 1 1
Cardiac Tamponade 1 1
Excessive Tear Production 1 1
Skin Irritation 1 1
Thrombosis 1 1
Transient Ischemic Attack 1 1
Ventricular Flutter 1 1
Ventricular Tachycardia 1 1
Rash 1 1
Irritation 1 1
Memory Loss/Impairment 1 1
Occlusion 1 1
Pulmonary Embolism 1 1
High Blood Pressure/ Hypertension 1 1
Atrial Tachycardia 1 1
Burn(s) 1 1
Cerebrospinal Fluid Leakage 1 1
Congestive Heart Failure 1 1
Cyst(s) 1 1
Dysphagia/ Odynophagia 1 1
Emotional Changes 1 1
Endocarditis 1 1
Chest Pain 1 1
Apnea 1 1
Bruise/Contusion 1 1
Foreign Body Reaction 1 1
Granuloma 1 1
Hemoptysis 1 1
Edema 1 1
Left Ventricular Dysfunction 1 1
Itching Sensation 1 1
Arthralgia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AESDEX II Jul-13-2018
2 Aesculap Implant Systems LLC II Apr-02-2018
3 Applied Medical Resources Corp II May-06-2016
4 AtriCure, Inc. II Feb-08-2017
5 AtriCure, Inc. II Nov-09-2016
6 Ethicon Endo-Surgery Inc II Dec-06-2019
7 Genicon, Inc. II Oct-30-2020
8 LeMaitre Vascular, Inc. II Jul-25-2016
9 Teleflex Medical II Nov-19-2019
10 Teleflex Medical II Nov-09-2017
11 Teleflex Medical II Aug-03-2016
12 Teleflex Medical II Feb-25-2016
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