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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
2019 62 62
2020 158 158
2021 149 149
2022 83 83
2023 74 76
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 113 113
Break 102 102
Device-Device Incompatibility 87 87
Delivered as Unsterile Product 42 42
Adverse Event Without Identified Device or Use Problem 38 38
Crack 27 27
Material Deformation 23 23
Fluid/Blood Leak 18 18
Material Separation 14 14
Detachment of Device or Device Component 11 11
Material Twisted/Bent 10 10
Contamination /Decontamination Problem 10 10
Mechanical Jam 9 9
Entrapment of Device 8 8
Material Integrity Problem 7 7
Device Contamination with Chemical or Other Material 5 5
Physical Resistance/Sticking 5 5
Material Fragmentation 5 5
Device Contaminated During Manufacture or Shipping 4 4
Temperature Problem 2 2
Fracture 2 2
Material Puncture/Hole 2 2
Contamination 2 2
Device Slipped 2 2
Defective Component 2 2
Incomplete or Missing Packaging 1 1
Solder Joint Fracture 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Structural Problem 1 1
Failure to Align 1 1
Defective Device 1 3
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Difficult to Open or Close 1 1
Partial Blockage 1 1
Burst Container or Vessel 1 1
Material Erosion 1 1
Positioning Failure 1 1
Disconnection 1 1
Material Rupture 1 1
Leak/Splash 1 1
Mechanical Problem 1 1
Misassembled 1 1
Nonstandard Device 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Component Misassembled 1 1
Complete Loss of Power 1 1
Missing Information 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Improper Flow or Infusion 1 1
Inadequate User Interface 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 294 296
No Consequences Or Impact To Patient 166 166
Foreign Body In Patient 16 16
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 14 14
Not Applicable 13 13
Pain 9 9
No Patient Involvement 8 8
Abscess 7 7
Hemorrhage/Bleeding 5 5
Unspecified Infection 5 5
Hernia 5 5
Device Embedded In Tissue or Plaque 4 4
Needle Stick/Puncture 4 4
Hematoma 4 4
Pleural Effusion 3 3
Inflammation 3 3
Failure to Anastomose 3 3
Wound Dehiscence 3 3
Abdominal Pain 3 3
Obstruction/Occlusion 3 3
Cardiac Tamponade 3 3
Seroma 3 3
No Code Available 3 3
Peritonitis 2 2
Post Operative Wound Infection 2 2
Blood Loss 2 2
Burn(s) 2 2
Fever 2 2
Fistula 2 2
Sepsis 2 2
Pneumothorax 1 1
Nausea 1 1
Incontinence 1 1
Ectopic Pregnancy 1 1
Adhesion(s) 1 1
Bradycardia 1 1
Thromboembolism 1 1
Discomfort 1 1
Injury 1 1
Vomiting 1 1
Unintended Radiation Exposure 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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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