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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
DANNIK
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO SURGERY, LLC.
  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 2

MDR Year MDR Reports MDR Events
2019 2903 2955
2020 1760 1760
2021 1759 1759
2022 1575 1575
2023 1915 1915
2024 537 537

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanics Altered 2266 2266
Failure to Form Staple 1974 2026
Mechanical Problem 1295 1295
Difficult to Open or Close 1015 1015
Failure to Fire 985 985
Break 836 836
Detachment of Device or Device Component 468 468
Mechanical Jam 458 458
Positioning Failure 441 441
Activation, Positioning or Separation Problem 414 414
Material Deformation 238 238
Misfire 203 203
Device Slipped 201 201
Adverse Event Without Identified Device or Use Problem 188 188
Firing Problem 166 166
Device Fell 138 138
Failure to Advance 127 127
Insufficient Information 126 126
Failure to Align 117 117
Fail-Safe Problem 110 110
Entrapment of Device 87 87
Display or Visual Feedback Problem 80 80
No Apparent Adverse Event 78 78
Unintended Ejection 71 71
Noise, Audible 65 65
Physical Resistance/Sticking 54 54
Material Fragmentation 51 51
Loss of or Failure to Bond 50 50
Patient Device Interaction Problem 49 49
Appropriate Term/Code Not Available 47 47
Material Integrity Problem 40 40
Defective Device 34 34
Difficult to Remove 33 33
Material Twisted/Bent 31 31
Component Missing 30 30
Delivered as Unsterile Product 30 30
Migration 29 29
Use of Device Problem 28 28
Tear, Rip or Hole in Device Packaging 27 27
Product Quality Problem 26 26
Activation Failure 24 24
Device Dislodged or Dislocated 23 23
Leak/Splash 23 23
Positioning Problem 22 22
Fracture 21 21
Difficult or Delayed Positioning 20 20
Defective Component 19 19
Premature Activation 18 18
Difficult to Insert 18 18
Therapeutic or Diagnostic Output Failure 16 16
Ejection Problem 15 15
Activation Problem 15 15
Patient-Device Incompatibility 14 14
Material Separation 13 13
Component or Accessory Incompatibility 12 12
Unsealed Device Packaging 12 12
Unintended Movement 12 12
Manufacturing, Packaging or Shipping Problem 11 11
Loose or Intermittent Connection 11 11
Expiration Date Error 11 11
Improper or Incorrect Procedure or Method 10 10
Output Problem 10 10
Material Protrusion/Extrusion 10 10
Device Markings/Labelling Problem 10 10
Failure to Eject 10 10
Device Damaged by Another Device 9 9
Compatibility Problem 9 9
Separation Problem 8 8
Image Display Error/Artifact 8 8
Premature Separation 7 7
Packaging Problem 7 7
Shipping Damage or Problem 6 6
Material Puncture/Hole 5 5
No Device Output 5 5
Fluid/Blood Leak 5 5
Difficult to Advance 5 5
Material Split, Cut or Torn 5 5
Device Contamination with Chemical or Other Material 4 4
Crack 4 4
Precipitate in Device or Device Ingredient 4 4
Migration or Expulsion of Device 4 4
Deformation Due to Compressive Stress 4 4
Contamination /Decontamination Problem 3 3
Separation Failure 3 3
Retraction Problem 3 3
Device Handling Problem 3 3
Overcorrection 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Lack of Effect 2 2
Difficult or Delayed Separation 2 2
Material Too Rigid or Stiff 2 2
Material Rupture 2 2
Device Damaged Prior to Use 2 2
Difficult or Delayed Activation 2 2
Incomplete Coaptation 2 2
Device Displays Incorrect Message 2 2
Malposition of Device 2 2
Corroded 2 2
Complete Blockage 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5369 5369
No Consequences Or Impact To Patient 3680 3732
Insufficient Information 489 489
No Known Impact Or Consequence To Patient 296 296
Hemorrhage/Bleeding 185 185
No Information 160 160
No Code Available 127 127
No Patient Involvement 110 110
Unspecified Tissue Injury 106 106
Failure to Anastomose 58 58
Tissue Damage 49 49
Blood Loss 49 49
Foreign Body In Patient 47 47
Pain 40 40
Tissue Breakdown 31 31
Perforation of Vessels 22 22
Hematoma 21 21
Laceration(s) 18 18
Injury 18 18
Inflammation 16 16
Hypersensitivity/Allergic reaction 15 15
Unintended Radiation Exposure 15 15
Unspecified Infection 14 14
Perforation 13 13
Device Embedded In Tissue or Plaque 12 12
Not Applicable 10 10
Patient Problem/Medical Problem 10 10
Abscess 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Death 9 9
Abdominal Pain 9 9
Fistula 9 9
Abdominal Distention 9 9
Fluid Discharge 8 8
Failure of Implant 8 8
Anemia 8 8
Sepsis 8 8
Rash 7 7
Wound Dehiscence 7 7
Post Operative Wound Infection 7 7
Fatigue 6 6
Hemostasis 5 5
Thrombus 5 5
Nerve Damage 5 5
Obstruction/Occlusion 5 5
Vomiting 5 5
Peritonitis 5 5
Arthralgia 4 4
Discomfort 4 4
Unspecified Kidney or Urinary Problem 4 4
Thrombosis/Thrombus 4 4
Radiation Exposure, Unintended 4 4
Nausea 4 4
Low Blood Pressure/ Hypotension 4 4
Fever 4 4
Foreign Body Reaction 3 3
Exsanguination 3 3
Headache 3 3
Cardiac Arrest 3 3
Dyspnea 3 3
Itching Sensation 3 3
Unspecified Heart Problem 3 3
Renal Impairment 3 3
Intra-Abdominal Hemorrhage 3 3
Hematuria 3 3
Diaphoresis 3 3
Weight Changes 2 2
Hernia 2 2
Depression 2 2
Stenosis 2 2
Burning Sensation 2 2
Urinary Tract Infection 2 2
Dizziness 2 2
Skin Inflammation/ Irritation 2 2
Cough 2 2
Constipation 2 2
Scar Tissue 2 2
Necrosis 2 2
Neuropathy 2 2
Dysphagia/ Odynophagia 2 2
Dehydration 2 2
Hair Loss 2 2
Emotional Changes 2 2
Erythema 2 2
Swelling/ Edema 2 2
Urinary Incontinence 1 1
Granuloma 1 1
Incontinence 1 1
High Blood Pressure/ Hypertension 1 1
Diarrhea 1 1
Dry Eye(s) 1 1
Edema 1 1
Chest Pain 1 1
Cyst(s) 1 1
Apnea 1 1
Arrhythmia 1 1
Autoimmune Disorder 1 1
Exposure to Body Fluids 1 1
Occlusion 1 1
Pleural Effusion 1 1

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