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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
2021 47 50
2022 31 31
2023 27 27
2024 92 92
2025 38 38
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 45 45
Use of Device Problem 35 35
Detachment of Device or Device Component 27 27
Failure to Seal 25 25
Output Problem 15 15
Activation Problem 15 15
Activation Failure 13 13
Break 9 9
Mechanics Altered 6 6
Contamination 5 5
Difficult to Open or Close 5 5
Defective Device 4 4
Therapeutic or Diagnostic Output Failure 4 4
Material Deformation 4 4
Appropriate Term/Code Not Available 4 4
Activation, Positioning or Separation Problem 3 3
Compatibility Problem 3 3
Separation Problem 3 3
Display or Visual Feedback Problem 3 3
Material Separation 3 3
Device Appears to Trigger Rejection 3 3
Mechanical Problem 2 2
Loss of or Failure to Bond 2 2
Mechanical Jam 2 2
Material Integrity Problem 2 2
Material Fragmentation 2 2
Misfire 2 2
Failure to Cut 2 2
Delivered as Unsterile Product 2 2
Device Dislodged or Dislocated 2 2
Temperature Problem 1 1
Dull, Blunt 1 1
Continuous Firing 1 1
Device Displays Incorrect Message 1 1
Arcing 1 4
Loss of Power 1 1
Electrical /Electronic Property Problem 1 1
Firing Problem 1 1
Insufficient Heating 1 1
Device Reprocessing Problem 1 1
Material Protrusion/Extrusion 1 1
Device Sensing Problem 1 1
Failure to Fire 1 1
Tear, Rip or Hole in Device Packaging 1 1
Retraction Problem 1 1
Packaging Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Unable to Obtain Readings 1 1
Difficult to Remove 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 167 167
Insufficient Information 47 47
Hemorrhage/Bleeding 22 22
Foreign Body In Patient 4 4
Unspecified Infection 3 3
Hematoma 3 3
Ischemia 2 2
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
Bowel Burn 1 4
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
Heart Block 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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