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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
Regulation Description Endoscope and accessories.
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
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
APOLLO CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 3
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 13
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MINI LAP TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 3
OPUSMED INC.
  SUBSTANTIALLY EQUIVALENT 4
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUTURA, INC.
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Detachment of device or device component 18
Detachment of device component 16
Break 12
Sticking 6
Difficult to open or close 6
Mechanical jam 5
Device operates differently than expected 3
Unknown (for use when the device problem is not known) 3
Bent 3
Slippage of device or device component 3
Device Difficult to Setup or Prepare 2
Difficult to remove 2
Difficult to advance 2
No code available 2
Out-of-box failure 2
Failure to disconnect 2
Device or device fragments location unknown 2
Device, removal of (non-implant) 1
Failure to fire 1
Computer operating system issue 1
Connection issue 1
Failure to form staple 1
Defective item 1
Device Issue 1
Dislodged or dislocated 1
Human-Device Interface Issue 1
Replace 1
Component(s), broken 1
Defective component 1
Component falling 1
Foreign material 1
Material fragmentation 1
Difficult to insert 1
Loose or intermittent connection 1
Mechanical issue 1
Migration of device or device component 1
Needle, separation 1
Premature deployment 1
Total Device Problems 110

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