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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 157 157

Device Problems MDRs with this Device Problem Events in those MDRs
Break 746 746
Detachment of Device or Device Component 690 690
Human-Device Interface Problem 535 535
Detachment Of Device Component 393 393
Component or Accessory Incompatibility 160 160
Adverse Event Without Identified Device or Use Problem 147 147
Difficult to Open or Close 100 100
Mechanical Jam 66 66
Entrapment of Device 59 59
Mechanical Problem 52 52
Device Operates Differently Than Expected 44 44
Insufficient Information 42 42
Difficult to Remove 36 36
Physical Resistance/Sticking 30 30
Failure to Align 24 24
Sticking 24 24
Misfire 21 21
Bent 20 20
Material Twisted/Bent 18 18
Mechanics Altered 18 18
Appropriate Term/Code Not Available 17 17
Defective Device 15 15
Device Difficult to Setup or Prepare 13 13
Device Slipped 11 11
Unraveled Material 11 11
Activation, Positioning or Separation Problem 10 10
Device Dislodged or Dislocated 10 10
Difficult to Insert 10 10
Use of Device Problem 9 9
Migration 9 9
Device Fell 9 9
Failure to Fire 9 9
Device-Device Incompatibility 8 8
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
Unintended Ejection 6 6
Material Fragmentation 6 6
Material Separation 6 6
Failure to Form Staple 6 6
Output Problem 6 6
Device Inoperable 6 6
Material Split, Cut or Torn 6 6
Failure To Adhere Or Bond 5 5
Material Integrity Problem 5 5
Difficult or Delayed Positioning 5 5
Difficult to Advance 5 5
Torn Material 5 5

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 437 437
No Consequences Or Impact To Patient 335 335
Foreign Body In Patient 185 185
Insufficient Information 150 150
No Code Available 117 117
Unintended Radiation Exposure 113 113
Radiation Exposure, Unintended 83 83
Device Embedded In Tissue or Plaque 82 82
No Information 57 57
Unspecified Tissue Injury 44 44
Hemorrhage/Bleeding 43 43
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
Abdominal Pain 12 12
Patient Problem/Medical Problem 12 12
Abnormal Vaginal Discharge 12 12
Scar Tissue 12 12
Perforation of Esophagus 11 11
Unspecified Infection 8 8
Injury 8 8
Vomiting 8 8
Gastrointestinal Hemorrhage 8 8
Pulmonary Embolism 8 8
Bowel Perforation 6 6
Nausea 6 6
Failure of Implant 6 6
Pneumothorax 6 6
Sepsis 5 5
Hematoma 5 5
Inflammation 5 5
Abscess 5 5
Ulcer 5 5
Laceration(s) of Esophagus 5 5
Fever 5 5
Blood Loss 5 5
Perforation of Vessels 4 4
Failure to Anastomose 4 4
Fistula 4 4
Organ Dehiscence 4 4
Laceration(s) 4 4
Internal Organ Perforation 4 4
Hemostasis 4 4
Pancreatitis 4 4
Death 4 4
Discomfort 4 4
Peritonitis 3 3

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