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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, ultrasonic surgical
Product CodeLFL
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
AMERICAN OPTISURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AOMORI OLYMPUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
AROBELLA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AXYA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOPERVISION
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 26
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 6
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KIRWAN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 1
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 2
MISONIX, INC.
  SUBSTANTIALLY EQUIVALENT 7
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 6
RADIONICS, INC
  SUBSTANTIALLY EQUIVALENT 4
SOERING GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOUND SURGICAL TECHNOLOGIES LLC.
  SUBSTANTIALLY EQUIVALENT 2
SPEMBLY CRYOSURGERY
  SUBSTANTIALLY EQUIVALENT 1
SRA DEVELOPMENTS, LTD.
  SUBSTANTIALLY EQUIVALENT 3
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 9

Device Problems
Break 1795
Replace 987
Device displays error message 799
Detachment of device component 519
Device inoperable 339
Component falling 320
Device Issue 265
Detachment of device or device component 175
Device operates differently than expected 160
System fails to activate 138
Fracture 90
Inability to irrigate 82
Overheating of device or device component 81
Device, removal of (non-implant) 75
Melted 71
Tip breakage 59
Failure to cut 57
Component(s), broken 52
Mechanical issue 51
Alarm, audible 48
No Information 46
No Known Device Problem 44
Loose 43
Noise 43
Crack 37
Sticking 36
Device or device fragments location unknown 35
Difficult to open or close 35
Failure to power-up 32
Smoking 28
Unknown (for use when the device problem is not known) 28
Failure, intermittent 28
Slippage of device or device component 27
Component missing 26
Difficult or delayed activation 26
Repair 22
Self-activation or keying 20
Burn of device or device component 20
Mechanical jam 19
Device stops intermittently 18
Peeled 17
Material separation 16
Defective component 15
Malfunction 15
Temperature issue 14
Material fragmentation 13
Device alarm system issue 12
Agglutinate, failure to 11
Failure to Adhere or Bond 11
Device damaged prior to use 11
Noise, Audible 11
Defective item 10
Device emits odor 10
Loose or intermittent connection 9
Loss of power 8
Prompts will not clear 7
Tear, rip or hole in device packaging 7
Failure to align 7
Application interface becomes non-functional or program exits abnormally 7
Component(s), overheating of 7
Failure to deliver energy 7
Disconnection 6
Loss of or failure to bond 6
Split 6
Improper or incorrect procedure or method 6
Device remains activated 6
Dislodged or dislocated 6
Material deformation 6
Material integrity issue 5
Failure of device to self-test 5
Difficult to remove 5
Other (for use when an appropriate device code cannot be identified) 5
Bent 5
Connection error 4
Electrical issue 4
Handpiece break 4
Foreign material 4
Hole in material 4
Use of Device Issue 4
Tears, rips, holes in device, device material 4
Device, or device fragments remain in patient 4
Normal 4
Foreign material present in device 4
Device handling issue 4
Output issue 4
Packaging issue 4
Power source issue 4
Electronic property issue 4
Failure to fire 4
Failure to separate 3
Failure to shut off 3
Unintended collision 3
Failure to advance 3
Out-of-box failure 3
High impedance 3
Heat 3
Flaked 3
Fluid leak 3
No display or display failure 3
Energy output to patient tissue incorrect 3
Total Device Problems 7165

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 1 4 4 4 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 American Optisurgical Inc II Aug-08-2013
2 American Optisurgical Inc II Jun-07-2013
3 American Optisurgical Inc II Jun-06-2013
4 Arobella Medical, LLC II Dec-17-2012
5 Ethicon Endo-Surgery Inc II Nov-16-2015
6 Ethicon Endo-Surgery Inc II May-25-2012
7 Ethicon Endo-Surgery Inc II Mar-21-2012
8 Integra LifeSciences Corp II Mar-15-2012
9 Integra LifeSciences Corp. II Dec-01-2014
10 Integra LifeSciences Corp. II Apr-29-2014
11 Integra LifeSciences Corp. II Sep-30-2010
12 Integra Limited II Jun-17-2011
13 Stryker Instruments Div. of Stryker Corporation II Apr-13-2016
14 Stryker Instruments Div. of Stryker Corporation II Aug-07-2014
15 Stryker Instruments Div. of Stryker Corporation II Aug-06-2013
16 Tenex Health Inc II May-06-2014

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