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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 11
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 4
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
Self-activation or keying 485
Failure to prime 328
Break 260
Failure to obtain samples 255
Device operates differently than expected 146
Device displays error message 122
Failure to fire 82
Difficult to remove 55
Replace 46
Device markings issue 43
No Known Device Problem 43
Detachment of device or device component 40
Mechanical issue 34
Tear, rip or hole in device packaging 32
Crack 27
Detachment of device component 26
Repair 24
Sticking 24
Foreign material present in device 23
Other (for use when an appropriate device code cannot be identified) 22
Bent 22
Misfire 19
Material separation 15
Device damaged prior to use 14
Device inoperable 14
Unsealed device packaging 14
Failure to cycle 13
No display or display failure 13
Device Issue 13
Failure to cut 13
Noise 12
Packaging issue 12
Device packaging compromised 11
Component(s), broken 11
Normal 10
Failure to power-up 10
Material fragmentation 10
Suction issue 10
Unknown (for use when the device problem is not known) 10
Noise, Audible 10
No code available 9
Loose 9
Loss of power 8
Use of Device Issue 8
Defective component 7
Difficult or delayed activation 7
Loose or intermittent connection 7
No Information 7
Fracture 6
Device Difficult to Setup or Prepare 6
Slippage of device or device component 6
Cable, defective 5
Malfunction 5
Defective item 5
Electronic property issue 5
Material integrity issue 4
Mechanical jam 4
Failure to disconnect 4
Unstable 4
Failure to reset 4
Retraction problem 4
Difficult to position 4
Device emits odor 4
Material frayed 4
Difficult to insert 4
Filling problem 4
Unintended ejection 3
Fluid leak 3
Connection error 3
Failure to deploy 3
Cable break 3
Poor quality image 3
Needle, separation 3
Device, or device fragments remain in patient 3
Premature deployment 3
Tip breakage 3
Fitting problem 3
Vacuum, loss of 3
Dull 3
Split 3
Connection issue 3
Device-device incompatibility 3
Difficult to open or close 3
Mechanics altered 3
Expulsion 3
Maintenance does not comply to manufacturers recommendations 2
Positioning Issue 2
Device handling issue 2
Loss of Data 2
Device misassembled during manufacturing or shipping 2
Malposition of device 2
Vibration 2
Metal shedding debris 2
Improper or incorrect procedure or method 2
System fails to activate 2
Shipping damage or problem 2
Failure to read input signal 2
Probe failure 2
Nonstandard device or device component 2
Monitor failure 2
Total Device Problems 2604

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

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