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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition 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 CodeNUJ
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
GREEN OR, LLC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 59 59
2021 47 50
2022 31 31
2023 27 27
2024 92 92
2025 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 79 79
Use of Device Problem 42 42
Detachment of Device or Device Component 28 28
Failure to Seal 23 23
Activation Problem 14 14
Activation Failure 12 12
Break 11 11
Output Problem 11 11
Mechanics Altered 6 6
Defective Device 5 5
Appropriate Term/Code Not Available 4 4
Therapeutic or Diagnostic Output Failure 4 4
Material Separation 4 4
Material Deformation 4 4
Compatibility Problem 3 3
Separation Problem 3 3
Display or Visual Feedback Problem 3 3
Difficult to Open or Close 3 3
Device Appears to Trigger Rejection 3 3
Material Fragmentation 3 3
Failure to Cut 3 3
Temperature Problem 2 2
Loss of or Failure to Bond 2 2
Mechanical Jam 2 2
Device Displays Incorrect Message 2 2
Device Sensing Problem 2 2
Delivered as Unsterile Product 2 2
Misfire 2 2
Contamination 2 2
Material Integrity Problem 2 2
Defective Component 2 2
Device Fell 2 2
Mechanical Problem 2 2
Entrapment of Device 2 2
Activation, Positioning or Separation Problem 2 2
Unable to Obtain Readings 1 1
Packaging Problem 1 1
Difficult to Remove 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Fire 1 1
Positioning Problem 1 1
Device Reprocessing Problem 1 1
Melted 1 1
Insufficient Information 1 1
Firing Problem 1 1
Peeled/Delaminated 1 1
Loss of Power 1 1
Arcing 1 4
Physical Resistance/Sticking 1 1
Continuous Firing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 170 170
Insufficient Information 45 45
No Consequences Or Impact To Patient 28 28
Hemorrhage/Bleeding 18 18
No Known Impact Or Consequence To Patient 11 11
Blood Loss 4 4
Foreign Body In Patient 4 4
Unspecified Infection 3 3
Hematoma 3 3
Ischemia 2 2
Bowel Burn 2 5
Burn(s) 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Adhesion(s) 1 1
Exsanguination 1 1
Perforation 1 1
Multiple Organ Failure 1 1
Laceration(s) 1 1
Renal Impairment 1 1
Failure to Anastomose 1 1
Unspecified Tissue Injury 1 1
Great Vessel Perforation 1 1
Tissue Breakdown 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 Medline Industries, LP II Nov-07-2025
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