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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
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
VEIN360, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 20 20
2020 59 59
2021 47 47
2022 31 31
2023 27 27
2024 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 76 76
Use of Device Problem 39 39
Detachment of Device or Device Component 22 22
Failure to Seal 11 11
Activation Problem 10 10
Activation Failure 10 10
Output Problem 10 10
Break 6 6
Mechanics Altered 6 6
Therapeutic or Diagnostic Output Failure 4 4
Material Deformation 4 4
Difficult to Open or Close 4 4
Defective Device 4 4
Compatibility Problem 3 3
Display or Visual Feedback Problem 3 3
Entrapment of Device 3 3
Material Fragmentation 3 3
Mechanical Problem 3 3
Appropriate Term/Code Not Available 3 3
Physical Resistance/Sticking 3 3
Device Fell 2 2
Melted 2 2
Delivered as Unsterile Product 2 2
Defective Component 2 2
Activation, Positioning or Separation Problem 2 2
Loss of or Failure to Bond 2 2
Failure to Cut 2 2
Device Dislodged or Dislocated 2 2
Device Ingredient or Reagent Problem 1 1
Device Sensing Problem 1 1
Device Displays Incorrect Message 1 1
Failure to Fire 1 1
Material Integrity Problem 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Misfire 1 1
Arcing 1 1
Overheating of Device 1 1
Peeled/Delaminated 1 1
Loss of Power 1 1
Unable to Obtain Readings 1 1
Failure to Sense 1 1
Material Separation 1 1
Contamination 1 1
Accessory Incompatible 1 1
Device Alarm System 1 1
Material Split, Cut or Torn 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 128 128
No Consequences Or Impact To Patient 35 35
Insufficient Information 24 24
No Known Impact Or Consequence To Patient 17 17
Hemorrhage/Bleeding 15 15
Blood Loss 6 6
Foreign Body In Patient 6 6
Hematoma 3 3
No Code Available 2 2
Ischemia 2 2
Bowel Burn 2 2
Burn(s) 1 1
Exsanguination 1 1
Failure to Anastomose 1 1
Adhesion(s) 1 1
Perforation 1 1
Tissue Damage 1 1
Multiple Organ Failure 1 1
Renal Impairment 1 1
Unspecified Tissue Injury 1 1
No Patient Involvement 1 1
Tissue Breakdown 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Oct-16-2023
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