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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
Tear, Rip or Hole in Device Packaging 12 12
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
Device Contamination with Chemical or Other Material 7 7
Material Fragmentation 7 7
Entrapment of Device 6 6
Device Contaminated During Manufacture or Shipping 5 5
Appropriate Term/Code Not Available 5 5
Physical Resistance/Sticking 5 5
Insufficient Information 3 3
Fracture 3 3
Leak/Splash 2 2
Detachment Of Device Component 2 2
Contamination 2 2
Device Slipped 2 2
Material Puncture/Hole 2 2
Temperature Problem 2 2
Material Integrity Problem 2 2
Device Operates Differently Than Expected 2 2
Patient-Device Incompatibility 2 2
Device Dislodged or Dislocated 2 2
Difficult to Open or Close 1 1
Device Contamination With Biological Material 1 1
Improper Flow or Infusion 1 1
Inadequate User Interface 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Complete Loss of Power 1 1
Missing Information 1 1
Device Handling Problem 1 1
Material Rupture 1 1
Unsealed Device Packaging 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Failure to Align 1 1
Use of Device Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Solder Joint Fracture 1 1
Disconnection 1 1
Burst Container or Vessel 1 1
Partial Blockage 1 1
Loss of or Failure to Bond 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
Material Erosion 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
Obstruction/Occlusion 9 9
Post Operative Wound Infection 9 9
Pain 8 8
Seroma 7 7
Hernia 7 7
Blood Loss 7 7
Hematoma 6 6
Inflammation 5 5
Fever 5 5
Device Embedded In Tissue or Plaque 5 5
Insufficient Information 5 5
Hemorrhage/Bleeding 4 4
Failure to Anastomose 3 3
Wound Dehiscence 3 3
Sepsis 3 3
No Information 3 3
Vomiting 2 2
Necrosis 2 2
Peritonitis 2 2
Needle Stick/Puncture 2 2
Abdominal Pain 2 2
Burn(s) 2 2
Cellulitis 1 1
Purulent Discharge 1 1
Ectopic Pregnancy 1 1
Edema 1 1
Adhesion(s) 1 1
Bradycardia 1 1
Low Blood Pressure/ Hypotension 1 1
Incontinence 1 1
Fistula 1 1
Nausea 1 1
Premature Labor 1 1
Injury 1 1
Infection, Pyrogenic 1 1
Pleural Effusion 1 1
Pneumothorax 1 1
Tachycardia 1 1
Cardiac Tamponade 1 1
Thromboembolism 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unintended Radiation Exposure 1 1
Swelling/ Edema 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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