Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device clip, implantable
Product CodeFZP
Regulation Number 878.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
A2 MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 1
AMSEL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DANNIK
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO SURGERY, LLC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 1
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEURAMEDICA INC
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2718 2718
2019 2903 2955
2020 1760 1760
2021 1759 1759
2022 1575 1575
2023 1432 1432

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanics Altered 2621 2621
Failure to Form Staple 2171 2223
Mechanical Problem 1464 1464
Difficult to Open or Close 1368 1368
Break 1019 1019
Failure to Fire 752 752
Mechanical Jam 593 593
Activation, Positioning or Separation Problem 556 556
Detachment of Device or Device Component 536 536
Positioning Failure 396 396
Material Deformation 310 310
Misfire 289 289
Device Slipped 270 270
Firing Problem 246 246
Adverse Event Without Identified Device or Use Problem 224 224
Device Fell 158 158
Failure to Align 146 146
Failure to Advance 138 138
Fail-Safe Problem 137 137
Insufficient Information 128 128
Loss of or Failure to Bond 123 123
Entrapment of Device 101 101
Display or Visual Feedback Problem 99 99
Unintended Ejection 79 79
Detachment Of Device Component 76 76
Noise, Audible 71 71
Physical Resistance/Sticking 67 67
Device Operates Differently Than Expected 65 65
No Apparent Adverse Event 62 62
Premature Activation 61 61
Material Fragmentation 59 59
Device Dislodged or Dislocated 53 53
Appropriate Term/Code Not Available 51 51
Material Integrity Problem 49 49
Material Twisted/Bent 49 49
Failure To Adhere Or Bond 49 49
Difficult to Remove 48 48
Patient Device Interaction Problem 48 48
Defective Device 47 47
Component Missing 39 39
Tear, Rip or Hole in Device Packaging 32 32
Product Quality Problem 31 31
Unintended Movement 31 31
Positioning Problem 30 30
Fracture 30 30
Loose or Intermittent Connection 30 30
Use of Device Problem 28 28
Migration 28 28
Activation Failure 27 27
Leak/Splash 27 27
Delivered as Unsterile Product 27 27
Difficult or Delayed Positioning 26 26
Defective Component 24 24
Premature Separation 20 20
Component Falling 19 19
Difficult to Insert 19 19
Unsealed Device Packaging 18 18
Patient-Device Incompatibility 18 18
Therapeutic or Diagnostic Output Failure 17 17
Material Separation 17 17
Separation Failure 16 16
Activation Problem 15 15
Ejection Problem 15 15
Device Markings/Labelling Problem 13 13
Improper or Incorrect Procedure or Method 12 12
Material Puncture/Hole 12 12
Device Inoperable 11 11
Expiration Date Error 11 11
Failure to Eject 11 11
Output Problem 10 10
Component or Accessory Incompatibility 10 10
Material Protrusion/Extrusion 10 10
Sticking 10 10
Image Display Error/Artifact 10 10
Fluid/Blood Leak 10 10
Crack 9 9
Compatibility Problem 9 9
Device Damaged by Another Device 9 9
Separation Problem 9 9
Packaging Problem 8 8
Manufacturing, Packaging or Shipping Problem 8 8
Migration or Expulsion of Device 8 8
Physical Resistance 7 7
Material Split, Cut or Torn 7 7
Difficult to Advance 6 6
Precipitate in Device or Device Ingredient 6 6
No Device Output 5 5
Device Contamination with Chemical or Other Material 5 5
Torn Material 5 5
Device Packaging Compromised 4 4
Deformation Due to Compressive Stress 4 4
Malposition of Device 4 4
Material Rupture 4 4
Shipping Damage or Problem 4 4
Retraction Problem 4 4
Material Too Rigid or Stiff 3 3
Fitting Problem 3 3
Device Damaged Prior to Use 3 3
Failure to Discharge 3 3
Bent 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5298 5350
No Clinical Signs, Symptoms or Conditions 4433 4433
No Known Impact Or Consequence To Patient 1217 1217
Insufficient Information 450 450
No Code Available 204 204
Hemorrhage/Bleeding 196 196
No Information 190 190
No Patient Involvement 151 151
Unspecified Tissue Injury 99 99
Blood Loss 84 84
Tissue Damage 76 76
Failure to Anastomose 65 65
Foreign Body In Patient 55 55
Pain 41 41
Injury 30 30
Perforation of Vessels 25 25
Not Applicable 23 23
Hematoma 22 22
Device Embedded In Tissue or Plaque 19 19
Unspecified Infection 18 18
Inflammation 18 18
Laceration(s) 17 17
Perforation 16 16
Tissue Breakdown 14 14
Hypersensitivity/Allergic reaction 11 11
Abscess 11 11
Abdominal Pain 10 10
Death 10 10
Fistula 10 10
Patient Problem/Medical Problem 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Unintended Radiation Exposure 9 9
Fluid Discharge 9 9
Abdominal Distention 8 8
Post Operative Wound Infection 8 8
Wound Dehiscence 8 8
Anemia 8 8
Thrombus 8 8
Sepsis 8 8
Rash 7 7
Failure of Implant 6 6
Nerve Damage 6 6
Low Blood Pressure/ Hypotension 5 5
Hemostasis 5 5
Peritonitis 5 5
Obstruction/Occlusion 5 5
Radiation Exposure, Unintended 4 4
Thrombosis/Thrombus 4 4
Unspecified Kidney or Urinary Problem 4 4
Discomfort 4 4
Fatigue 4 4
Cardiac Arrest 4 4
Fever 3 3
Dyspnea 3 3
Exsanguination 3 3
Itching Sensation 3 3
Stenosis 3 3
Vomiting 3 3
Arthralgia 3 3
Hematuria 3 3
Intra-Abdominal Hemorrhage 3 3
Unspecified Heart Problem 3 3
Cough 2 2
Constipation 2 2
Skin Inflammation/ Irritation 2 2
Weight Changes 2 2
Depression 2 2
Burning Sensation 2 2
Urinary Tract Infection 2 2
Urticaria 2 2
Dizziness 2 2
Hernia 2 2
Scar Tissue 2 2
Seroma 2 2
Neuropathy 2 2
Nausea 2 2
Necrosis 2 2
Emotional Changes 2 2
Erythema 2 2
Foreign Body Reaction 2 2
Hair Loss 2 2
Headache 2 2
Stroke/CVA 2 2
Dysphagia/ Odynophagia 2 2
Renal Impairment 2 2
Urinary Incontinence 1 1
Swelling/ Edema 1 1
Dehydration 1 1
Diarrhea 1 1
Dry Eye(s) 1 1
Chest Pain 1 1
Cyst(s) 1 1
Apnea 1 1
Arrhythmia 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Hemoptysis 1 1
High Blood Pressure/ Hypertension 1 1
Granuloma 1 1
Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AESDEX II Jul-13-2018
2 Aesculap Implant Systems LLC II Sep-27-2021
3 Aesculap Implant Systems LLC II Apr-02-2018
4 Ethicon Endo-Surgery Inc II Dec-06-2019
5 Genicon, Inc. II Oct-30-2020
6 TELEFLEX LLC II May-30-2023
7 Teleflex Medical II Nov-19-2019
-
-