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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, biopsy
Regulation Description Gastroenterology-urology biopsy instrument.
Product CodeKNW
Regulation Number 876.1075
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
BUSSE HOSPITAL DISPOSABLES, INC.
  SUBSTANTIALLY EQUIVALENT 3
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 9
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
CIVCO
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENDOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENGINEERED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 8
H.S. HOSPITAL SERVICES S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
HAAKO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IMAGYN MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
INRAD
  SUBSTANTIALLY EQUIVALENT 6
INTACT MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 10
MEADOX
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 15
MEDINVENTS
  SUBSTANTIALLY EQUIVALENT 2
NEOTHERMIA
  SUBSTANTIALLY EQUIVALENT 1
Ohio Medical Corporation
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 3
PARALLAX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
PNEUMEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
Remington Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 3
RUBICOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SANARUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SOMATEX MEDICAL TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
VANCE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIDACARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device displays error message 117
Failure to obtain samples 64
Replace 46
Break 37
Repair 24
Other (for use when an appropriate device code cannot be identified) 22
Device operates differently than expected 21
Mechanical issue 17
Difficult to remove 16
Detachment of device component 15
Sticking 14
Device damaged prior to use 13
Crack 13
No display or display failure 12
Noise 12
Device Issue 12
Component(s), broken 11
Unknown (for use when the device problem is not known) 10
Failure to power-up 10
Misfire 10
Normal 10
Loose 9
Material separation 9
Failure to cut 9
Loss of power 8
Defective component 7
Difficult or delayed activation 7
Loose or intermittent connection 6
Device inoperable 6
No Known Device Problem 5
Cable, defective 5
Malfunction 5
Unsealed device packaging 5
No Information 5
No code available 5
Defective item 4
Bent 4
Fracture 4
Material frayed 4
Difficult to insert 3
Self-activation or keying 3
Unstable 3
Tip breakage 3
Material integrity issue 3
Poor quality image 3
Needle, separation 3
Material fragmentation 3
Cable break 3
Device emits odor 3
Device, or device fragments remain in patient 3
Connection error 3
Retraction problem 3
Slippage of device or device component 3
Detachment of device or device component 3
Suction issue 3
Split 3
Vacuum, loss of 3
System fails to activate 2
Use of Device Issue 2
Maintenance does not comply to manufacturers recommendations 2
Disassembly 2
Probe failure 2
Foreign material 2
Failure to deploy 2
Mechanical jam 2
Device maintenance issue 2
Failure to read input signal 2
Loss of Data 2
Burn of device or device component 2
Monitor failure 2
Malposition of device 2
Connection issue 2
Positioning Issue 1
Locking mechanism failure 1
Close, difficult to 1
Device markings issue 1
Fail-safe mechanism issue 1
Failure to disconnect 1
Kinked 1
Image orientation incorrect 1
Component(s), worn 1
Decrease in suction 1
Disconnection 1
Failure, intermittent 1
Failure to fire 1
Optical issue 1
Unintended movement 1
Vibration 1
Improper or incorrect procedure or method 1
Failure to advance 1
Device stops intermittently 1
Adaptor, failure of 1
Corrosion 1
Shock, electrical 1
Image resolution poor 1
Size incorrect for patient 1
Failure to service 1
Operating system version or upgrade problem 1
Design/structure problem 1
Calcified 1
Total Device Problems 725

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

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc III Oct-22-2008
2 Hologic, Inc. II Aug-26-2010
3 Hologic, Inc. III Mar-18-2010
4 Hologic, Inc. II Nov-07-2008
5 Medical Device Technologies, Inc. II Jul-13-2010
6 Medical Device Technologies, Inc. II Jan-06-2009
7 Remington Medical Inc. II Oct-09-2012
8 Remington Medical Inc. II Mar-07-2011
9 Remington Medical Inc. II Mar-29-2007
10 Suros Surgical Systems Inc. II Jan-23-2007
11 Theken Spine LLC II Nov-18-2008

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