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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
STERILMED
  SUBSTANTIALLY EQUIVALENT 3
STERILMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 28
Energy Output To Patient Tissue Incorrect 16
Device Displays Incorrect Message 15
Detachment of Device or Device Component 15
Detachment Of Device Component 12
Use of Device Problem 10
Energy Output Problem 9
Melted 6
Device Remains Activated 4
Material Separation 4
Thermal Decomposition of Device 4
Material Fragmentation 4
Device Inoperable 3
Failure to Cut 3
Adhesive 2
Smoking 2
Split 2
Fracture 2
Difficult to Open or Close 2
Appropriate Term/Code Not Available 2
Noise, Audible 2
Electrical /Electronic Property Problem 1
Adverse Event Without Identified Device or Use Problem 1
Activation Problem 1
Charred 1
Component Missing 1
Device Difficult to Setup or Prepare 1
Device Operational Issue 1
Environmental Particulates 1
Peeled/Delaminated 1
Component Falling 1
Deformation Due to Compressive Stress 1
Insufficient Information 1
Audible Prompt/Feedback Problem 1
Pad 1
Total Device Problems 161

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Sustainability Solutions II Jul-18-2018

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