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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 5
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 1732
Replace 987
Device displays error message 799
Detachment of device component 503
Device inoperable 338
Component falling 320
Device Issue 265
Detachment of device or device component 175
Device operates differently than expected 155
System fails to activate 138
Device, removal of (non-implant) 75
Melted 71
Overheating of device or device component 68
Tip breakage 59
Component(s), broken 52
Alarm, audible 48
Failure to cut 48
Mechanical issue 47
Fracture 46
Loose 43
Noise 43
No Information 42
Sticking 37
Crack 37
Inability to irrigate 36
Difficult to open or close 36
Device or device fragments location unknown 35
No Known Device Problem 32
Failure to power-up 30
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
Burn of device or device component 20
Self-activation or keying 19
Mechanical jam 19
Peeled 18
Material separation 16
Malfunction 15
Defective component 14
Device stops intermittently 13
Material fragmentation 13
Temperature issue 13
Noise, Audible 11
Device alarm system issue 11
Agglutinate, failure to 11
Failure to Adhere or Bond 11
Device damaged prior to use 11
Device emits odor 10
Loose or intermittent connection 9
Energy output to patient tissue incorrect 9
Defective item 9
Loss of power 8
Prompts will not clear 7
Failure to deliver energy 7
Application interface becomes non-functional or program exits abnormally 7
Component(s), overheating of 7
Disconnection 6
Improper or incorrect procedure or method 6
Tear, rip or hole in device packaging 6
Split 6
Difficult to remove 6
Dislodged or dislocated 6
Material deformation 5
Failure of device to self-test 5
Device remains activated 5
Failure to align 5
Other (for use when an appropriate device code cannot be identified) 5
Loss of or failure to bond 5
Bent 5
Connection error 4
Handpiece break 4
Foreign material 4
Hole in material 4
Normal 4
Device, or device fragments remain in patient 4
Tears, rips, holes in device, device material 4
Material integrity issue 4
Device handling issue 4
Packaging issue 4
Power source issue 3
Output issue 3
Failure to shut off 3
Foreign material present in device 3
Failure to fire 3
Use of Device Issue 3
Out-of-box failure 3
Failure to advance 3
Failure to separate 3
Unintended collision 3
Heat 3
High impedance 3
Flaked 3
Fluid leak 3
No display or display failure 3
Electrical issue 3
Error or warning message, failure to produce 3
Total Device Problems 6932

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