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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device single-use reprocessed ultrasonic surgical instruments
Definition Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNLQ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
STERILMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 45 45
2020 28 28
2021 40 40
2022 31 31
2023 16 16
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 32 32
Detachment of Device or Device Component 26 26
Use of Device Problem 19 19
Fracture 17 17
Energy Output Problem 9 9
Material Deformation 9 9
Device Remains Activated 7 7
Difficult to Open or Close 6 6
Melted 5 5
Mechanical Problem 5 5
Physical Resistance/Sticking 4 4
Appropriate Term/Code Not Available 4 4
Smoking 4 4
Device Fell 3 3
Crack 3 3
Defective Device 2 2
Loss of Power 2 2
Therapeutic or Diagnostic Output Failure 2 2
Failure to Cut 2 2
Contamination /Decontamination Problem 2 2
Device Displays Incorrect Message 1 1
Connection Problem 1 1
Activation Failure 1 1
Device Dislodged or Dislocated 1 1
Deformation Due to Compressive Stress 1 1
Component Missing 1 1
Defective Component 1 1
Failure to Fire 1 1
Battery Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Sparking 1 1
Material Fragmentation 1 1
Peeled/Delaminated 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Temperature Problem 1 1
Thermal Decomposition of Device 1 1
No Audible Prompt/Feedback 1 1
Audible Prompt/Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69 69
No Consequences Or Impact To Patient 43 43
No Known Impact Or Consequence To Patient 14 14
Insufficient Information 13 13
Blood Loss 8 8
Foreign Body In Patient 8 8
Hemorrhage/Bleeding 3 3
No Patient Involvement 2 2
Death 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Oct-16-2023
2 Stryker Sustainability Solutions II Mar-31-2021
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