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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscope and/or accessories
Regulation Description Endoscope and accessories.
Product CodeKOG
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGEION CORP.
  SUBSTANTIALLY EQUIVALENT 1
APOLLO CORP.
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 19
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 17
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 4
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
CUSTOM ULTRASONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 15
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
GIMMI GMBH
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 23
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
LSI SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MECTRA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 2
MEDIVATORS REPROCESSING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MINI LAP TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 3
MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
NORTH AMERICAN STERILIZATION & PACKAGING CO.
  SUBSTANTIALLY EQUIVALENT 1
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 24
OPUSMED INC.
  SUBSTANTIALLY EQUIVALENT 4
OR SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
PENTAX
  SUBSTANTIALLY EQUIVALENT 16
PRESERVATION SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROPPER MFG
  SUBSTANTIALLY EQUIVALENT 1
RADIUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 9
SCHOLLY FIBEROPTIC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
SOPRO
  SUBSTANTIALLY EQUIVALENT 2
SPIRUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUPERIOR HEALTHCARE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 2
SURGITEK
  SUBSTANTIALLY EQUIVALENT 1
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TRIMEDYNE, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 4
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 3
VANCE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VISION-SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 3
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 2
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 4
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 9
XODUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 165
Dislodged or dislocated 77
Retraction problem 67
Valve(s), failure of 62
Burst 61
Break 50
Leak 46
Detachment of device component 40
Balloon rupture 38
Fluid leak 35
Decrease in suction 27
No Known Device Problem 24
Failure to form staple 22
Replace 22
Locking mechanism failure 22
Normal 21
Device Cleaning Issue 21
Device Issue 20
No code available 20
Dislodged 19
Deflation issue 19
Tears, rips, holes in device, device material 18
Material deformation 18
Difficult to remove 18
Mechanical issue 16
Hole in material 15
Unknown (for use when the device problem is not known) 15
No Information 13
Failure to deploy 12
Failure to fire 11
Sticking 11
Fumes or vapors 11
Balloon burst 11
Torn material 10
Inflation issue 10
Failure to advance 10
Material perforation 9
Device clogged 9
No display or display failure 8
Disinfection or Sterilization Issue at User Location 8
Device inoperable 8
Device damaged prior to use 7
Kinked 7
Residue after decontamination 7
Fracture 6
Chemical issue 6
Device operates differently than expected 6
Balloon leak(s) 5
Manufacturing or shipping issue associated with device 5
Component(s), broken 5
Connection issue 4
Physical resistance 4
Device disinfection or sterilization issue 4
Use of Device Issue 4
Image resolution poor 4
Misfire 4
Detachment of device or device component 4
Bent 4
Improper or incorrect procedure or method 4
Image display error 3
Ventilation issue in device environment 3
Difficult to insert 3
Component falling 3
Source, detachment from 3
Tip breakage 3
Failure to disinfect 3
Difficult to position 3
Difficult to open or close 3
Not Applicable 3
Material frayed 3
Device or device fragments location unknown 3
Poor quality image 2
Connection error 2
Peeled 2
Component or accessory incompatibility 2
Balloon pinhole 2
Entrapment of device or device component 2
Unsealed device packaging 2
Sharp/jagged/rough/etched/scratched 2
Unintended ejection 2
Device, or device fragments remain in patient 2
Slippage of device or device component 2
Loose 2
Spark 2
Crack 2
Malfunction 2
Failure to power-up 2
Foreign material 2
Wire(s), breakage of 2
Reaction 1
Failure to separate 1
Failure to remove enzymatic cleaner 1
Environmental Particulates 1
Trocar failure 1
Defective component 1
Material Protrusion 1
Failure to pump 1
Packaging issue 1
Out-of-box failure 1
Application interface becomes non-functional or program exits abnormally 1
Total Device Problems 1292

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 3 1 0 2 1 3 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Dec-16-2010
2 Boston Scientific Corporation II Mar-31-2007
3 Custom Ultrasonics, Inc. II Mar-07-2008
4 Ethicon, Inc. II Jul-07-2011
5 Innovatech Medical Resources L.P. II Jan-11-2012
6 NDO Surgical, Inc. II Mar-31-2007
7 Olympus America Inc. II Mar-18-2010
8 Teleflex Medical II Apr-16-2012
9 US Endoscopy Group Inc II Sep-17-2012
10 Vision Systems Group, A Div of Viking Systems II Jun-06-2007

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