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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic tissue approximation device
Definition To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.
Product CodeOCW
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ANCHORA MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
APOLLO ENDOSURGERY
  SUBSTANTIALLY EQUIVALENT 2
APOLLO ENDOSURGERY INC
  SUBSTANTIALLY EQUIVALENT 1
APOLLO ENDOSURGERY INC.
  SUBSTANTIALLY EQUIVALENT 2
AXIOM TECHNOLOGY PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
BAROSENSE, INC
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
  SUBSTANTIALLY EQUIVALENT 1
ENDO TOOLS THERAPEUTICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
ENDOGASTRIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH VALUE CREATION BV, TRADING AS CORPORIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDEON BIODESIGN, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDEON BIODESIGN, INC.
  SUBSTANTIALLY EQUIVALENT 1
MINI LAP TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MINILAP TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MIRET SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SUTUREEASE, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
USGI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 28 28
2015 57 57
2016 73 73
2017 418 418
2018 413 413
2019 290 290
2020 182 182
2021 198 198
2022 235 235
2023 227 227
2024 63 63

Device Problems MDRs with this Device Problem Events in those MDRs
Break 697 697
Detachment of Device or Device Component 651 651
Human-Device Interface Problem 522 522
Detachment Of Device Component 393 393
Component or Accessory Incompatibility 157 157
Adverse Event Without Identified Device or Use Problem 140 140
Difficult to Open or Close 95 95
Mechanical Jam 66 66
Entrapment of Device 54 54
Mechanical Problem 52 52
Device Operates Differently Than Expected 44 44
Insufficient Information 42 42
Difficult to Remove 32 32
Physical Resistance/Sticking 29 29
Sticking 24 24
Failure to Align 23 23
Misfire 21 21
Bent 20 20
Mechanics Altered 18 18
Material Twisted/Bent 17 17
Appropriate Term/Code Not Available 17 17
Defective Device 15 15
Device Difficult to Setup or Prepare 13 13
Unraveled Material 11 11
Activation, Positioning or Separation Problem 10 10
Difficult to Insert 10 10
Device Dislodged or Dislocated 10 10
Migration 9 9
Device Fell 9 9
Failure to Fire 9 9
Use of Device Problem 9 9
Device Slipped 9 9
Loose or Intermittent Connection 8 8
Therapeutic or Diagnostic Output Failure 8 8
Component Falling 7 7
Material Too Rigid or Stiff 7 7
Patient-Device Incompatibility 7 7
Failure to Form Staple 6 6
Device Inoperable 6 6
Unintended Ejection 6 6
Material Fragmentation 6 6
Output Problem 6 6
Material Split, Cut or Torn 6 6
Torn Material 5 5
Device-Device Incompatibility 5 5
Difficult to Advance 5 5
Material Integrity Problem 5 5
Difficult or Delayed Positioning 5 5
Failure To Adhere Or Bond 5 5
Material Perforation 5 5
Improper or Incorrect Procedure or Method 4 4
Failure to Advance 4 4
Defective Component 4 4
Positioning Failure 4 4
Fracture 4 4
Product Quality Problem 4 4
Device Contamination with Chemical or Other Material 4 4
No Apparent Adverse Event 4 4
Premature Separation 3 3
Noise, Audible 3 3
Positioning Problem 3 3
Leak/Splash 3 3
Nonstandard Device 3 3
Component Missing 3 3
Material Separation 3 3
Connection Problem 3 3
Dull, Blunt 3 3
Difficult or Delayed Activation 3 3
Failure to Disconnect 2 2
Separation Failure 2 2
Device Or Device Fragments Location Unknown 2 2
Device Operational Issue 2 2
Premature Activation 2 2
Material Puncture/Hole 2 2
Migration or Expulsion of Device 2 2
Difficult To Position 2 2
Material Frayed 2 2
Fluid/Blood Leak 2 2
Component Incompatible 2 2
Patient Device Interaction Problem 2 2
Activation Problem 2 2
Separation Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Ejection Problem 1 1
Firing Problem 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Scratched Material 1 1
Unintended Movement 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Accessory Incompatible 1 1
Partial Blockage 1 1
Difficult to Fold, Unfold or Collapse 1 1
Hole In Material 1 1
Electrical /Electronic Property Problem 1 1
Material Erosion 1 1
Loss of Power 1 1
Unable to Obtain Readings 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 755 755
No Clinical Signs, Symptoms or Conditions 377 377
No Consequences Or Impact To Patient 335 335
Foreign Body In Patient 164 164
Insufficient Information 143 143
No Code Available 117 117
Unintended Radiation Exposure 95 95
Radiation Exposure, Unintended 83 83
Device Embedded In Tissue or Plaque 82 82
No Information 57 57
Unspecified Tissue Injury 43 43
Hemorrhage/Bleeding 40 40
Tissue Damage 38 38
Pain 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
No Patient Involvement 17 17
Perforation 16 16
Abnormal Vaginal Discharge 12 12
Scar Tissue 12 12
Patient Problem/Medical Problem 12 12
Perforation of Esophagus 11 11
Abdominal Pain 11 11
Unspecified Infection 8 8
Vomiting 8 8
Injury 8 8
Gastrointestinal Hemorrhage 8 8
Pulmonary Embolism 7 7
Failure of Implant 6 6
Pneumothorax 6 6
Nausea 6 6
Bowel Perforation 6 6
Laceration(s) of Esophagus 5 5
Blood Loss 5 5
Sepsis 5 5
Ulcer 5 5
Inflammation 5 5
Hematoma 5 5
Fever 5 5
Abscess 5 5
Failure to Anastomose 4 4
Death 4 4
Fistula 4 4
Hemostasis 4 4
Internal Organ Perforation 4 4
Perforation of Vessels 4 4
Laceration(s) 4 4
Organ Dehiscence 4 4
Pancreatitis 4 4
Cramp(s) /Muscle Spasm(s) 3 3
Peritonitis 3 3
Excessive Tear Production 3 3
Anxiety 3 3
Discomfort 3 3
Fatigue 3 3
Emotional Changes 3 3
Wound Dehiscence 3 3
Adhesion(s) 3 3
Dehydration 2 2
Diarrhea 2 2
Dyspnea 2 2
Cardiac Arrest 2 2
Chest Pain 2 2
Incontinence 2 2
Depression 2 2
Liver Damage/Dysfunction 2 2
Necrosis 2 2
Pneumonia 2 2
Tachycardia 2 2
Stomach Ulceration 2 2
Thrombosis/Thrombus 2 2
Lethargy 2 2
Ascites 2 2
Suture Abrasion 2 2
Obstruction/Occlusion 2 2
Intermenstrual Bleeding 2 2
Fluid Discharge 2 2
Constipation 2 2
Syncope/Fainting 1 1
Neuralgia 1 1
Fibrosis 1 1
Not Applicable 1 1
Dysuria 1 1
Intraoperative Pain 1 1
Post Operative Wound Infection 1 1
Post Traumatic Wound Infection 1 1
Diaphoresis 1 1
Respiratory Tract Infection 1 1
Abdominal Distention 1 1
Sleep Dysfunction 1 1
Abdominal Cramps 1 1
Ambulation Difficulties 1 1
Implant Pain 1 1
Unspecified Kidney or Urinary Problem 1 1
Genital Bleeding 1 1
Swelling/ Edema 1 1
Renal Failure 1 1
Urinary Tract Infection 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Impaired Healing 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LP II Feb-06-2024
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