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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cannula, surgical, general & plastic surgery
Product CodeGEA
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 58 58
2019 62 62
2020 158 158
2021 149 149
2022 83 83

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 112 112
Break 89 89
Device-Device Incompatibility 65 65
Adverse Event Without Identified Device or Use Problem 50 50
Delivered as Unsterile Product 37 37
Crack 23 23
Fluid/Blood Leak 15 15
Material Deformation 15 15
Contamination /Decontamination Problem 12 12
Detachment of Device or Device Component 11 11
Material Separation 10 10
Material Twisted/Bent 8 8
Mechanical Jam 8 8
Material Fragmentation 6 6
Device Contamination with Chemical or Other Material 6 6
Entrapment of Device 6 6
Device Contaminated During Manufacture or Shipping 5 5
Physical Resistance/Sticking 5 5
Tear, Rip or Hole in Device Packaging 3 3
Fracture 3 3
Insufficient Information 3 3
Appropriate Term/Code Not Available 3 3
Temperature Problem 2 2
Material Puncture/Hole 2 2
Device Slipped 2 2
Device Operates Differently Than Expected 2 2
Patient-Device Incompatibility 2 2
Material Integrity Problem 2 2
Contamination 2 2
Leak/Splash 1 1
Defective Component 1 1
Solder Joint Fracture 1 1
Partial Blockage 1 1
Detachment Of Device Component 1 1
Missing Information 1 1
Component or Accessory Incompatibility 1 1
Burst Container or Vessel 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Device Handling Problem 1 1
Use of Device Problem 1 1
Failure to Align 1 1
Melted 1 1
Nonstandard Device 1 1
No Apparent Adverse Event 1 1
Difficult to Open or Close 1 1
Improper Flow or Infusion 1 1
Inadequate User Interface 1 1
Packaging Problem 1 1
Loss of or Failure to Bond 1 1
Material Erosion 1 1
Material Rupture 1 1
Device Damaged Prior to Use 1 1
Connection Problem 1 1
Complete Loss of Power 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 218 218
No Consequences Or Impact To Patient 181 181
Not Applicable 27 27
No Known Impact Or Consequence To Patient 20 20
Abscess 19 19
Foreign Body In Patient 15 15
No Code Available 12 12
No Patient Involvement 12 12
Unspecified Infection 11 11
Post Operative Wound Infection 9 9
Obstruction/Occlusion 9 9
Pain 8 8
Blood Loss 7 7
Hernia 7 7
Seroma 7 7
Hematoma 6 6
Inflammation 5 5
Insufficient Information 5 5
Fever 4 4
Hemorrhage/Bleeding 4 4
No Information 3 3
Failure to Anastomose 3 3
Sepsis 3 3
Wound Dehiscence 3 3
Device Embedded In Tissue or Plaque 3 3
Needle Stick/Puncture 2 2
Burn(s) 2 2
Peritonitis 2 2
Necrosis 2 2
Abdominal Pain 2 2
Bradycardia 1 1
Cellulitis 1 1
Ectopic Pregnancy 1 1
Edema 1 1
Nausea 1 1
Thromboembolism 1 1
Swelling/ Edema 1 1
Unintended Radiation Exposure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Low Blood Pressure/ Hypotension 1 1
Premature Labor 1 1
Adhesion(s) 1 1
Purulent Discharge 1 1
Fistula 1 1
Incontinence 1 1
Pleural Effusion 1 1
Pneumothorax 1 1
Tachycardia 1 1
Vomiting 1 1
Infection, Pyrogenic 1 1
Injury 1 1
Cardiac Tamponade 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CLINICAL LASERTHERMIA SYSTEMS AB II Jun-04-2021
2 Cardinal Health 200, LLC II Mar-09-2020
3 Genicon, Inc. II Jun-05-2020
4 TeDan Surgical Innovations LLC II May-01-2020
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