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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 47
2022 31 31
2023 27 27
2024 92 92
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 79 79
Use of Device Problem 41 41
Detachment of Device or Device Component 26 26
Failure to Seal 21 21
Activation Problem 14 14
Break 11 11
Activation Failure 10 10
Output Problem 10 10
Mechanics Altered 6 6
Defective Device 5 5
Appropriate Term/Code Not Available 4 4
Material Separation 4 4
Material Deformation 4 4
Therapeutic or Diagnostic Output Failure 4 4
Failure to Cut 3 3
Separation Problem 3 3
Compatibility Problem 3 3
Difficult to Open or Close 3 3
Display or Visual Feedback Problem 3 3
Defective Component 2 2
Device Fell 2 2
Material Integrity Problem 2 2
Material Fragmentation 2 2
Delivered as Unsterile Product 2 2
Mechanical Problem 2 2
Entrapment of Device 2 2
Device Sensing Problem 2 2
Device Displays Incorrect Message 2 2
Loss of or Failure to Bond 2 2
Temperature Problem 2 2
Activation, Positioning or Separation Problem 2 2
Positioning Problem 1 1
Insufficient Information 1 1
Contamination 1 1
Difficult to Remove 1 1
Unable to Obtain Readings 1 1
Misfire 1 1
Peeled/Delaminated 1 1
Physical Resistance/Sticking 1 1
Packaging Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Fire 1 1
Device Ingredient or Reagent Problem 1 1
Melted 1 1
Firing Problem 1 1
Loss of Power 1 1
Arcing 1 1
Continuous Firing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 161 161
Insufficient Information 40 40
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
Hematoma 3 3
Ischemia 2 2
Bowel Burn 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
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
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