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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device light, surgical, ceiling mounted
Regulation Description Surgical lamp.
Product CodeFSY
Regulation Number 878.4580
Device Class 2


Premarket Reviews
ManufacturerDecision
ALM
  SUBSTANTIALLY EQUIVALENT 3
BERCHTOLD CORP.
  SUBSTANTIALLY EQUIVALENT 11
BURTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
CONMED
  SUBSTANTIALLY EQUIVALENT 1
DR. MACH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GETINGE
  SUBSTANTIALLY EQUIVALENT 2
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAVIG GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ILLUMINATION
  SUBSTANTIALLY EQUIVALENT 1
NUVO, INC.
  SUBSTANTIALLY EQUIVALENT 1
SKYTRON
  SUBSTANTIALLY EQUIVALENT 6
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
TRUMPF MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Detachment of device component 210
Component falling 175
Dislodged or dislocated 40
Other (for use when an appropriate device code cannot be identified) 39
Material disintegration 24
Material integrity issue 24
Use of Device Issue 21
Break 19
Flaked 19
Material separation 16
Smoking 15
Device operates differently than expected 15
Crack 15
Detachment of device or device component 14
Corrosion 13
Fracture 10
Component(s), broken 8
Pitted 8
Component(s), overheating of 7
Electrical issue 7
Mechanical issue 7
Disinfection, inadequate/improper 6
Material fragmentation 6
Metal shedding debris 6
Maintenance does not comply to manufacturers recommendations 6
Component missing 5
Device Issue 5
Fire 5
Migration of device or device component 5
Connector pin failure 5
Degraded 5
Material erosion 4
Device emits odor 4
Instruction for use issue 4
Loose or intermittent connection 4
Buckled material 4
Output energy incorrect 4
No Known Device Problem 4
Unintended movement 3
Material deformation 3
Positioning Issue 3
Temperature issue 3
Loss of power 3
Installation-related problem 3
Unintended collision 3
Dislodged 2
Burn of device or device component 2
Improper or incorrect procedure or method 2
Spark 2
Difficult to position 2
Slippage of device or device component 2
Unstable 2
No Information 2
Optical issue 1
Torn material 1
Unauthorized access to computer system 1
Moisture or humidity problem 1
Failure to osseointegrate 1
Sticking 1
Failure to service 1
No device output 1
Failure to power-up 1
Product quality issue 1
Repair 1
Malfunction 1
Structural problem 1
Arcing 1
Fuse, blown 1
Light interference 1
Device or device component damaged by another device 1
Device unsafe to use in environment 1
Environmental control or utility issue 1
Failure to shut off 1
Inadequate lighting 1
Unintended arm motion 1
Component(s), worn 1
Computer failure 1
Disassembly 1
Misassembled 1
Normal 1
Melted 1
Loose 1
Device maintenance issue 1
Heat 1
Total Device Problems 856

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 2 1 2 5 2 2 6 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beaver-Visitec International Inc. II Jun-15-2015
2 Covidien LLC II Jul-20-2015
3 MAQUET Inc. II Nov-12-2009
4 Maquet Cardiovascular Us Sales, Llc II Jul-07-2015
5 Maquet Medical Systems USA II Jun-06-2014
6 Resource Optimization & Innovation Llc II Oct-07-2015
7 Siemens Medical Solutions USA, Inc II Dec-12-2012
8 Steris Corporation II Jun-23-2014
9 Steris Corporation II Apr-05-2011
10 Stryker Communications Corp II Jan-26-2012
11 Stryker Communications Corp II Oct-28-2011
12 Stryker Communications Corp II May-21-2010
13 Stryker Communications, Inc. II Jan-09-2013
14 Trumpf Medical Systems, Inc. II Dec-31-2015
15 Trumpf Medical Systems, Inc. II Aug-07-2015
16 Trumpf Medical Systems, Inc. II Dec-12-2013
17 Trumpf Medical Systems, Inc. II Oct-18-2012
18 Trumpf Medical Systems, Inc. II Sep-05-2012
19 Trumpf Medical Systems, Inc. II Feb-13-2012
20 Trumpf Medical Systems, Inc. II Apr-01-2009

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