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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 - KIT WITH DRUGS 2
  SUBSTANTIALLY EQUIVALENT 10
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
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMAGYN MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
INRAD
  SUBSTANTIALLY EQUIVALENT 6
INTACT MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
K2M
  SUBSTANTIALLY EQUIVALENT 1
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 10
MEADOX
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 15
MEDINVENTS
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOTHERMIA
  SUBSTANTIALLY EQUIVALENT 1
Ohio Medical Corporation
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 2
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 3
PARALLAX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
PNEUMEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
RANFAC, CORP
  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 7
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SOMATEX MEDICAL TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY
  SUBSTANTIALLY EQUIVALENT 2
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 1
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
Break 252
Failure to obtain samples 206
Failure to prime 148
Device displays error message 121
Self-activation or keying 78
Device operates differently than expected 70
Failure to fire 67
Replace 46
Difficult to remove 37
No Known Device Problem 36
Detachment of device or device component 30
Device markings issue 30
Tear, rip or hole in device packaging 30
Mechanical issue 28
Crack 26
Detachment of device component 25
Repair 24
Sticking 24
Other (for use when an appropriate device code cannot be identified) 22
Misfire 19
Material separation 15
Device inoperable 14
Device damaged prior to use 13
Failure to cut 13
Bent 13
No display or display failure 13
Failure to cycle 12
Unsealed device packaging 12
Device Issue 12
Noise 12
Foreign material present in device 11
Component(s), broken 11
Packaging issue 11
Normal 10
Failure to power-up 10
Unknown (for use when the device problem is not known) 10
Suction issue 9
Loose 9
Material fragmentation 9
No code available 9
Loss of power 8
Loose or intermittent connection 7
Defective component 7
Difficult or delayed activation 7
No Information 7
Noise, Audible 6
Slippage of device or device component 6
Cable, defective 5
Malfunction 5
Use of Device Issue 5
Defective item 5
Device packaging compromised 5
Fracture 5
Material frayed 4
Difficult to insert 4
Device emits odor 4
Failure to reset 4
Retraction problem 4
Filling problem 4
Failure to disconnect 4
Unstable 4
Material integrity issue 4
Mechanical jam 4
Mechanics altered 3
Device, or device fragments remain in patient 3
Vacuum, loss of 3
Fitting problem 3
Tip breakage 3
Split 3
Connection issue 3
Expulsion 3
Connection error 3
Failure to deploy 3
Cable break 3
Premature deployment 3
Device Difficult to Setup or Prepare 3
Needle, separation 3
Difficult to position 3
Poor quality image 3
Device maintenance issue 2
Monitor failure 2
Probe failure 2
Burn of device or device component 2
Contamination during use 2
Disconnection 2
Disassembly 2
Fluid leak 2
Foreign material 2
Maintenance does not comply to manufacturers recommendations 2
Loss of Data 2
Device misassembled during manufacturing or shipping 2
Difficult to open or close 2
Malposition of device 2
Vibration 2
Metal shedding debris 2
Improper or incorrect procedure or method 2
System fails to activate 2
Failure to read input signal 2
Positioning Issue 2
Protective measure issue 1
Total Device Problems 1754

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 1 0 0 0
Class II 2 2 1 2 1 1 0 1 6 2
Class III 0 1 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Jul-21-2015
2 Atossa Genetics, Inc. I Oct-28-2013
3 Bard Peripheral Vascular Inc II May-06-2015
4 Bard Peripheral Vascular Inc II Apr-14-2015
5 Bard Peripheral Vascular Inc III Oct-22-2008
6 Cook Medical Incorporated II Oct-24-2014
7 Hologic, Inc II Sep-21-2016
8 Hologic, Inc. II Aug-26-2010
9 Hologic, Inc. III Mar-18-2010
10 Hologic, Inc. II Nov-07-2008
11 Medical Device Technologies, Inc. II Jul-13-2010
12 Medical Device Technologies, Inc. II Jan-06-2009
13 Orthovita, Inc., dBA Stryker Orthobiologics. II Jan-07-2015
14 Remington Medical Inc. II Oct-09-2012
15 Remington Medical Inc. II Mar-07-2011
16 Remington Medical Inc. II Mar-29-2007
17 Stryker Instruments Div. of Stryker Corporation II Jul-18-2015
18 Stryker Instruments Div. of Stryker Corporation II May-26-2015
19 Suros Surgical Systems Inc. II Jan-23-2007
20 Teleflex Medical II Nov-30-2016
21 Theken Spine LLC II Nov-18-2008

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