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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device scalpel, ultrasonic, reprocessed
Definition The ultrasonic scalpel is intended for incision and excision of soft tissues. This device is indicated for reuse/reprocessing.
Product CodeNLQ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCENT HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
MEDISISS
  SUBSTANTIALLY EQUIVALENT 1
STERILMED
  SUBSTANTIALLY EQUIVALENT 6
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material fragmentation 13
Break 10
Device operates differently than expected 8
Melted 7
Burn of device or device component 5
Loss of or failure to bond 4
No Information 4
Self-activation or keying 3
Detachment of device component 3
Continuous firing 3
Material disintegration 2
Device inoperable 2
Failure to auto stop 2
Detachment of device or device component 2
Failure to shut off 1
Foreign material present in device 1
Item contaminated during manufacturing or shipping 1
No Known Device Problem 1
Noise, Audible 1
Difficult to open or close 1
Electronic property issue 1
Tear, rip or hole in device packaging 1
Device or device fragments location unknown 1
Device displays error message 1
Smoking 1
Source, detachment from 1
Bent 1
Fracture 1
Unintended system motion 1
Overheating of device or device component 1
Device remains activated 1
Difficult to remove 1
Total Device Problems 86

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

Recalls
Manufacturer Recall Class Date Posted
1 Sterilmed Inc II Jan-13-2009
2 Surgical Instrument Service And Savings, Inc. II Jul-01-2013

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