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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
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 4
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC.(DBA MEDLINE REN
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 28 28
2021 40 40
2022 31 32
2023 16 17
2024 19 19
2025 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 41 41
Use of Device Problem 27 27
Break 23 23
Detachment of Device or Device Component 18 18
Material Fragmentation 12 12
Material Deformation 9 9
Device Remains Activated 6 6
Mechanical Problem 5 5
Melted 5 5
Physical Resistance/Sticking 3 3
Crack 3 5
Appropriate Term/Code Not Available 3 3
Difficult to Open or Close 3 3
Energy Output Problem 2 3
Insufficient Information 2 2
Smoking 2 2
Contamination /Decontamination Problem 2 2
Activation Failure 2 2
Compatibility Problem 1 1
Peeled/Delaminated 1 1
Defective Device 1 2
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Battery Problem 1 1
Material Twisted/Bent 1 1
Structural Problem 1 1
No Audible Prompt/Feedback 1 1
Unstable Capture Threshold 1 1
Failure to Fire 1 1
Device Dislodged or Dislocated 1 1
Connection Problem 1 1
Temperature Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 118 119
Insufficient Information 17 18
No Consequences Or Impact To Patient 14 14
Foreign Body In Patient 11 11
No Known Impact Or Consequence To Patient 7 7
Hemorrhage/Bleeding 5 5
Blood Loss 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Burn(s) 1 1
No Patient Involvement 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Sep-10-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Oct-16-2023
3 Stryker Sustainability Solutions II Nov-12-2025
4 Stryker Sustainability Solutions II Mar-31-2021
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