TPLC - Total Product Life Cycle

• Device: apparatus, suction, operating-room, wall vacuum powered
• Product Code: GCX
• Regulation Number: 880.6740
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2018	49	49
2019	65	65
2020	65	65
2021	65	65
2022	72	72
2023	15	15

Device Problems	MDRs with this Device Problem	Events in those MDRs
Delivered as Unsterile Product	37	37
Suction Problem	37	37
Break	36	36
Contamination /Decontamination Problem	25	25
Suction Failure	25	25
Detachment of Device or Device Component	23	23
Leak/Splash	17	17
Packaging Problem	15	15
Obstruction of Flow	14	14
Fluid/Blood Leak	14	14
Crack	12	12
Contamination	11	11
Device Contamination with Chemical or Other Material	11	11
Device Contaminated During Manufacture or Shipping	10	10
Decrease in Suction	9	9
Material Fragmentation	8	8
Mechanical Problem	7	7
Corroded	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Appropriate Term/Code Not Available	4	4
Tear, Rip or Hole in Device Packaging	4	4
Fracture	4	4
Collapse	3	3
Detachment Of Device Component	3	3
Device Inoperable	3	3
No Flow	3	3
Sharp Edges	3	3
Insufficient Information	2	2
Temperature Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Output Problem	2	2
Material Deformation	2	2
Fitting Problem	2	2
Defective Component	2	2
Component Missing	2	2
Use of Device Problem	2	2
Vibration	2	2
Material Separation	2	2
Shipping Damage or Problem	2	2
Material Puncture/Hole	2	2
Thermal Decomposition of Device	2	2
Burst Container or Vessel	2	2
Complete Blockage	2	2
Clumping in Device or Device Ingredient	1	1
Coagulation in Device or Device Ingredient	1	1
Loose or Intermittent Connection	1	1
Deflation Problem	1	1
Material Discolored	1	1
Entrapment of Device	1	1
Product Quality Problem	1	1
Difficult to Remove	1	1
Melted	1	1
Energy Output Problem	1	1
Pacing Problem	1	1
Particulates	1	1
Loss of Power	1	1
Smoking	1	1
Problem with Sterilization	1	1
Sticking	1	1
Unexpected Therapeutic Results	1	1
Improper or Incorrect Procedure or Method	1	1
Structural Problem	1	1
Defective Device	1	1
Device Or Device Fragments Location Unknown	1	1
Sparking	1	1
Aspiration Issue	1	1
Battery Problem	1	1
Connection Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Improper Flow or Infusion	1	1
Device Markings/Labelling Problem	1	1
Difficult to Open or Close	1	1
Material Integrity Problem	1	1
Material Twisted/Bent	1	1
Scratched Material	1	1
Misassembly by Users	1	1
No Apparent Adverse Event	1	1
Component Misassembled	1	1
Device Fell	1	1
Activation Problem	1	1
Unintended Deflation	1	1
Wrong Label	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	138	138
No Known Impact Or Consequence To Patient	76	76
Insufficient Information	54	54
No Consequences Or Impact To Patient	22	22
No Patient Involvement	20	20
Foreign Body In Patient	9	9
Hemorrhage/Bleeding	8	8
No Information	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Death	5	5
Laceration(s)	4	4
Pneumothorax	4	4
Pulmonary Edema	2	2
Unspecified Infection	2	2
Pain	2	2
Hemothorax	2	2
Exposure to Body Fluids	2	2
Cardiac Arrest	2	2
Aspiration/Inhalation	2	2
No Code Available	2	2
Device Embedded In Tissue or Plaque	2	2
Vomiting	2	2
Blood Loss	2	2
Ulcer	1	1
Discomfort	1	1
Burn, Thermal	1	1
Pleural Empyema	1	1
Bacterial Infection	1	1
Airway Obstruction	1	1
Anemia	1	1
Deposits	1	1
Low Blood Pressure/ Hypotension	1	1
Liver Laceration(s)	1	1
Respiratory Distress	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardinal Health 200, LLC	II	Apr-30-2018
2	Stryker Corporation	II	Mar-02-2018
3	Synaptive Medical Inc	II	Jun-25-2021