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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 3
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 2
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 257
Failure to obtain samples 229
Self-activation or keying 208
Failure to prime 200
Device displays error message 122
Device operates differently than expected 106
Failure to fire 74
Difficult to remove 49
Replace 46
No Known Device Problem 39
Device markings issue 37
Detachment of device or device component 34
Mechanical issue 32
Tear, rip or hole in device packaging 31
Detachment of device component 26
Crack 26
Repair 24
Sticking 24
Other (for use when an appropriate device code cannot be identified) 22
Bent 20
Misfire 19
Foreign material present in device 18
Material separation 15
Device damaged prior to use 14
Device inoperable 14
Device Issue 13
Failure to cut 13
Failure to cycle 13
No display or display failure 13
Unsealed device packaging 13
Noise 12
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
Use of Device Issue 7
Difficult or delayed activation 7
Noise, Audible 7
No Information 7
Device packaging compromised 6
Slippage of device or device component 6
Fracture 6
Cable, defective 5
Defective item 5
Malfunction 5
Failure to disconnect 4
Electronic property issue 4
Unstable 4
Failure to reset 4
Retraction problem 4
Material frayed 4
Difficult to insert 4
Difficult to position 4
Device emits odor 4
Device Difficult to Setup or Prepare 4
Filling problem 4
Material integrity issue 4
Mechanical jam 4
Mechanics altered 3
Fluid leak 3
Connection error 3
Failure to deploy 3
Cable break 3
Device, or device fragments remain in patient 3
Premature deployment 3
Needle, separation 3
Poor quality image 3
Tip breakage 3
Vacuum, loss of 3
Fitting problem 3
Expulsion 3
Device-device incompatibility 3
Connection issue 3
Split 3
Dull 2
Loss of Data 2
Malposition of device 2
Difficult to open or close 2
Device misassembled during manufacturing or shipping 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
Device maintenance issue 2
Nonstandard device or device component 2
Monitor failure 2
Probe failure 2
Burn of device or device component 2
Contamination during use 2
Disconnection 2
Disassembly 2
Total Device Problems 2070

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 0 0
Class II 2 2 1 2 1 1 0 1 6 2 3
Class III 0 1 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Feb-13-2017
2 Argon Medical Devices, Inc II Jul-21-2015
3 Atossa Genetics, Inc. I Oct-28-2013
4 Bard Peripheral Vascular Inc II May-06-2015
5 Bard Peripheral Vascular Inc II Apr-14-2015
6 Bard Peripheral Vascular Inc III Oct-22-2008
7 Cook Medical Incorporated II Oct-24-2014
8 Devicor Medical Products Inc II Mar-08-2017
9 Hologic, Inc II Sep-21-2016
10 Hologic, Inc. II Aug-26-2010
11 Hologic, Inc. III Mar-18-2010
12 Hologic, Inc. II Nov-07-2008
13 Medical Device Technologies, Inc. II Jul-13-2010
14 Medical Device Technologies, Inc. II Jan-06-2009
15 Medtronic Advanced Energy, LLC II Feb-02-2017
16 Orthovita, Inc., dBA Stryker Orthobiologics. II Jan-07-2015
17 Remington Medical Inc. II Oct-09-2012
18 Remington Medical Inc. II Mar-07-2011
19 Remington Medical Inc. II Mar-29-2007
20 Stryker Instruments Div. of Stryker Corporation II Jul-18-2015
21 Stryker Instruments Div. of Stryker Corporation II May-26-2015
22 Suros Surgical Systems Inc. II Jan-23-2007
23 Teleflex Medical II Nov-30-2016
24 Theken Spine LLC II Nov-18-2008

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