• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device apparatus, suction, operating-room, wall vacuum powered
Regulation Description Vacuum-powered body fluid suction apparatus.
Product CodeGCX
Regulation Number 880.6740
Device Class 2

MDR Year MDR Reports MDR Events
2020 65 65
2021 65 65
2022 72 72
2023 59 59
2024 65 65
2025 144 144

Device Problems MDRs with this Device Problem Events in those MDRs
Smoking 51 51
Delivered as Unsterile Product 45 45
Break 40 40
Suction Failure 38 38
Temperature Problem 31 31
Suction Problem 31 31
Packaging Problem 27 27
Leak/Splash 26 26
Detachment of Device or Device Component 25 25
Fluid/Blood Leak 21 21
Material Fragmentation 17 17
Crack 16 16
Obstruction of Flow 14 14
Device Contamination with Chemical or Other Material 14 14
Mechanical Problem 14 14
Device Contaminated During Manufacture or Shipping 14 14
Contamination 13 13
Contamination /Decontamination Problem 13 13
Failure to Eject 12 12
Material Puncture/Hole 9 9
Pressure Problem 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Decrease in Suction 8 8
Complete Blockage 7 7
Corroded 6 6
Fracture 4 4
Overheating of Device 4 4
Nonstandard Device 3 3
Collapse 3 3
Insufficient Information 3 3
Material Separation 3 3
No Flow 3 3
Sharp Edges 3 3
Therapeutic or Diagnostic Output Failure 3 3
Shipping Damage or Problem 3 3
Noise, Audible 3 3
Power Problem 2 2
Failure to Conduct 2 2
No Apparent Adverse Event 2 2
Device Emits Odor 2 2
Continuous Firing 2 2
Decrease in Pressure 2 2
Use of Device Problem 2 2
Key or Button Unresponsive/not Working 2 2
Sparking 2 2
Entrapment of Device 2 2
Material Integrity Problem 2 2
Output Problem 2 2
Unsealed Device Packaging 2 2
Fumes or Vapors 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 367 367
Insufficient Information 74 74
No Known Impact Or Consequence To Patient 20 20
Foreign Body In Patient 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
No Consequences Or Impact To Patient 7 7
Laceration(s) 5 5
Hemorrhage/Bleeding 4 4
Pneumothorax 3 3
No Patient Involvement 3 3
Pulmonary Edema 3 3
Device Embedded In Tissue or Plaque 3 3
Death 2 2
No Code Available 2 2
Cardiac Arrest 2 2
Exposure to Body Fluids 2 2
Hemothorax 2 2
Pleural Empyema 1 1
Deposits 1 1
Discomfort 1 1
Ulcer 1 1
Unspecified Heart Problem 1 1
Unspecified Respiratory Problem 1 1
Bacterial Infection 1 1
Airway Obstruction 1 1
Low Blood Pressure/ Hypotension 1 1
Liver Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Jan-18-2024
2 Med Michigan Holding Llc II Dec-31-2024
3 Synaptive Medical Inc II Jun-25-2021
-
-