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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 1
APOLLO ENDOSURGERY INC.
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
ENDO TOOLS THERAPEUTICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH VALUE CREATION BV, TRADING AS CORPORIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDEON BIODESIGN, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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
Detachment of Device or Device Component 503 503
Break 445 445
Human-Device Interface Problem 257 257
Component or Accessory Incompatibility 135 135
Adverse Event Without Identified Device or Use Problem 115 115
Difficult to Open or Close 41 41
Mechanical Problem 40 40
Insufficient Information 39 39
Entrapment of Device 38 38
Physical Resistance/Sticking 25 25
Mechanical Jam 21 21
Difficult to Remove 20 20
Material Twisted/Bent 16 16
Failure to Align 15 15
Defective Device 14 14
Migration 9 9
Use of Device Problem 9 9
Therapeutic or Diagnostic Output Failure 8 8
Mechanics Altered 8 8
Activation, Positioning or Separation Problem 8 8
Patient-Device Incompatibility 6 6
Appropriate Term/Code Not Available 6 6
Material Split, Cut or Torn 6 6
Unintended Ejection 6 6
Difficult to Insert 6 6
Output Problem 5 5
Device-Device Incompatibility 5 5
Material Integrity Problem 5 5
Device Contamination with Chemical or Other Material 4 4
Improper or Incorrect Procedure or Method 4 4
Material Perforation 4 4
Misfire 4 4
Device Difficult to Setup or Prepare 4 4
No Apparent Adverse Event 4 4
Premature Separation 3 3
Product Quality Problem 3 3
Material Separation 3 3
Device Slipped 3 3
Defective Component 3 3
Component Missing 3 3
Dull, Blunt 3 3
Nonstandard Device 3 3
Fracture 3 3
Failure to Form Staple 3 3
Failure to Fire 3 3
Positioning Problem 3 3
Patient Device Interaction Problem 2 2
Difficult to Advance 2 2
Device Dislodged or Dislocated 2 2
Fluid/Blood Leak 2 2
Leak/Splash 2 2
Material Puncture/Hole 2 2
Activation Problem 2 2
Separation Problem 1 1
Partial Blockage 1 1
Retraction Problem 1 1
Material Too Rigid or Stiff 1 1
Failure to Disconnect 1 1
No Audible Prompt/Feedback 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Unintended Collision 1 1
Unintended System Motion 1 1
No Device Output 1 1
Loss of Power 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Fragmentation 1 1
Electrical /Electronic Property Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Connection Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Unintended Movement 1 1
Ejection Problem 1 1
Firing Problem 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 377 377
No Consequences Or Impact To Patient 208 208
Insufficient Information 143 143
Foreign Body In Patient 98 98
Unintended Radiation Exposure 95 95
No Known Impact Or Consequence To Patient 72 72
No Code Available 61 61
Device Embedded In Tissue or Plaque 51 51
Unspecified Tissue Injury 43 43
Hemorrhage/Bleeding 37 37
No Information 30 30
Radiation Exposure, Unintended 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Pain 18 18
Perforation 14 14
Tissue Damage 12 12
Perforation of Esophagus 11 11
Patient Problem/Medical Problem 11 11
Abdominal Pain 10 10
No Patient Involvement 9 9
Gastrointestinal Hemorrhage 8 8
Vomiting 8 8
Pulmonary Embolism 7 7
Unspecified Infection 7 7
Failure of Implant 6 6
Nausea 6 6
Pneumothorax 5 5
Ulcer 5 5
Hematoma 5 5
Fever 5 5
Abscess 5 5
Death 4 4
Injury 4 4
Sepsis 4 4
Perforation of Vessels 4 4
Pancreatitis 4 4
Bowel Perforation 4 4
Organ Dehiscence 4 4
Laceration(s) of Esophagus 3 3
Cramp(s) /Muscle Spasm(s) 3 3
Internal Organ Perforation 3 3
Peritonitis 3 3
Anxiety 3 3
Emotional Changes 3 3
Failure to Anastomose 3 3
Wound Dehiscence 3 3
Fistula 3 3
Fatigue 3 3
Hemostasis 3 3
Incontinence 2 2
Inflammation 2 2
Laceration(s) 2 2
Liver Damage/Dysfunction 2 2
Cardiac Arrest 2 2
Chest Pain 2 2
Dyspnea 2 2
Dehydration 2 2
Diarrhea 2 2
Discomfort 2 2
Depression 2 2
Obstruction/Occlusion 2 2
Excessive Tear Production 2 2
Tachycardia 2 2
Scar Tissue 2 2
Necrosis 2 2
Pneumonia 2 2
Suture Abrasion 2 2
Lethargy 2 2
Intermenstrual Bleeding 2 2
Fluid Discharge 2 2
Stomach Ulceration 2 2
Thrombosis/Thrombus 2 2
Constipation 2 2
Syncope/Fainting 1 1
Neuralgia 1 1
Fibrosis 1 1
Implant Pain 1 1
Unspecified Kidney or Urinary Problem 1 1
Genital Bleeding 1 1
Dysuria 1 1
Intraoperative Pain 1 1
Ascites 1 1
Abdominal Distention 1 1
Sleep Dysfunction 1 1
Abdominal Cramps 1 1
Ambulation Difficulties 1 1
Swelling/ Edema 1 1
Myalgia 1 1
Burning Sensation 1 1
Electrolyte Imbalance 1 1
Urinary Tract Infection 1 1
Abnormal Vaginal Discharge 1 1
Post Operative Wound Infection 1 1
Post Traumatic Wound Infection 1 1
Diaphoresis 1 1
Impaired Healing 1 1
Respiratory Tract Infection 1 1
Malaise 1 1
Deformity/ Disfigurement 1 1
Distress 1 1

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