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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, surgical instrument, ac-powered
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGEY
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Unintended system motion 941
Fail-safe mechanism issue 905
Mechanical jam 466
Device inoperable 353
Device operates differently than expected 272
Overheating of device or device component 107
Fluid leak 81
Noise, Audible 75
Mechanical issue 68
Failure to power-up 35
Detachment of device component 30
Sticking 29
Vibration 23
Break 23
Loss of power 22
Defective component 19
Loose or intermittent connection 18
Device stops intermittently 18
Difficult to position 15
Leak 15
Component missing 12
Battery issue 11
Failure to charge 10
Power source issue 10
Temperature issue 10
Output below specifications 8
Air leak 8
Defective item 8
Material separation 7
Difficult to remove 7
Component falling 7
Blockage within device or device component 7
Fracture 6
Device displays error message 6
Connection issue 6
Detachment of device or device component 6
Failure to shut off 6
Slippage of device or device component 5
Smoking 5
Naturally worn 5
No fail-safe mechanism 4
Fitting problem 4
Physical resistance 4
Difficult to insert 4
Power Conditioning Issue 4
Crack 4
Component incompatible 3
Failure to Adhere or Bond 3
Bent 3
Material disintegration 3
Device or device component damaged by another device 3
Device remains activated 3
Material rupture 2
Self-activation or keying 2
Device contamination with blood or blood product 2
Failure to calibrate 2
Unintended ejection 2
Hole in material 2
Positioning Issue 2
Material deformation 2
Torn material 2
Unintended movement 1
Misassembled by Users 1
Not Applicable 1
Device handling issue 1
Pressure issue 1
Material integrity issue 1
Material torqued 1
Moisture or humidity problem 1
Fail-safe design failure 1
No device output 1
Melted 1
Moisture damage 1
Device emits odor 1
Circuit Failure 1
Device clogged 1
Application interface becomes non-functional or program exits abnormally 1
Decoupling 1
Decrease in suction 1
Unintended energization 1
Disassembly 1
Failure to discharge 1
Disconnection 1
Structural problem 1
Failure to disconnect 1
Difficult or delayed activation 1
Improper or incorrect procedure or method 1
Difficult to open or close 1
Manufacturing or shipping issue associated with device 1
Retraction problem 1
Inappropriate shock 1
Unraveled material 1
Total Device Problems 3756

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 1 0 1 0 0 0 3 1 1 1
Class III 0 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Linvatec Corp. dba ConMed Linvatec III Mar-06-2013
2 Linvatec Corp. dba ConMed Linvatec II Jul-17-2010
3 MEDICAMAT S.A. II Mar-04-2014
4 Nico Corp. II Jun-21-2016
5 Nico Corp. II Sep-15-2015
6 Synthes U S A II Sep-21-2008
7 The Anspach Effort, Inc. II May-04-2017
8 The Anspach Effort, Inc. II Jun-25-2014
9 The Anspach Effort, Inc. II Jan-06-2014

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