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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
2017 46 46
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 118 118
Break 111 111
Device-Device Incompatibility 65 65
Adverse Event Without Identified Device or Use Problem 50 50
Delivered as Unsterile Product 37 37
Crack 23 23
Material Deformation 16 16
Fluid/Blood Leak 15 15
Contamination /Decontamination Problem 12 12
Tear, Rip or Hole in Device Packaging 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 7 7
Device Contamination with Chemical or Other Material 7 7
Entrapment of Device 6 6
Appropriate Term/Code Not Available 5 5
Device Contaminated During Manufacture or Shipping 5 5
Physical Resistance/Sticking 5 5
Fracture 3 3
Insufficient Information 3 3
Temperature Problem 2 2
Device Dislodged or Dislocated 2 2
Material Puncture/Hole 2 2
Device Slipped 2 2
Patient-Device Incompatibility 2 2
Device Operates Differently Than Expected 2 2
Material Integrity Problem 2 2
Detachment Of Device Component 2 2
Contamination 2 2
Leak/Splash 2 2
Defective Component 1 1
Solder Joint Fracture 1 1
Device Contamination With Biological Material 1 1
Missing Information 1 1
Partial Blockage 1 1
Device Handling Problem 1 1
Component or Accessory Incompatibility 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Burst Container or Vessel 1 1
Migration or Expulsion of Device 1 1
Unsealed Device Packaging 1 1
Use of Device Problem 1 1
Failure to Align 1 1
Melted 1 1
Nonstandard Device 1 1
Improper Flow or Infusion 1 1
Inadequate User Interface 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Difficult to Open or Close 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 206 206
No Known Impact Or Consequence To Patient 36 36
Not Applicable 29 29
Abscess 20 20
Foreign Body In Patient 15 15
No Code Available 14 14
No Patient Involvement 14 14
Unspecified Infection 12 12
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 5 5
Device Embedded In Tissue or Plaque 5 5
Hemorrhage/Bleeding 4 4
No Information 3 3
Failure to Anastomose 3 3
Sepsis 3 3
Wound Dehiscence 3 3
Needle Stick/Puncture 2 2
Vomiting 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
Infection, Pyrogenic 1 1
Injury 1 1
Premature Labor 1 1
Pleural Effusion 1 1
Pneumothorax 1 1
Tachycardia 1 1
Adhesion(s) 1 1
Purulent Discharge 1 1
Fistula 1 1
Incontinence 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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