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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
Regulation Description Manual surgical instrument for general use.
Product CodeGEA
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 63 63
2017 46 46
2018 58 58
2019 62 62
2020 158 158
2021 80 80

Device Problems MDRs with this Device Problem Events in those MDRs
Device Markings/Labelling Problem 109 109
Break 97 97
Tear, Rip or Hole in Device Packaging 42 42
Device-Device Incompatibility 36 36
Adverse Event Without Identified Device or Use Problem 35 35
Delivered as Unsterile Product 22 22
Appropriate Term/Code Not Available 15 15
Crack 13 13
Contamination /Decontamination Problem 12 12
Fluid Leak 9 9
Material Separation 8 8
Tip 8 8
Detachment of Device or Device Component 7 7
Material Fragmentation 7 7
Device Contamination with Chemical or Other Material 7 7
Material Deformation 5 5
Physical Resistance/Sticking 5 5
Material Twisted/Bent 5 5
Mechanical Jam 4 4
Device Contaminated During Manufacture or Shipping 4 4
Detachment Of Device Component 3 3
Entrapment of Device 3 3
Insufficient Information 3 3
Device Operates Differently Than Expected 3 3
Fracture 2 2
Patient-Device Incompatibility 2 2
Device Dislodged or Dislocated 2 2
Temperature Problem 2 2
Needle 2 2
Contamination 2 2
Leak/Splash 2 2
Cannula 2 2
Trocar 1 1
Material Integrity Problem 1 1
Partial Blockage 1 1
Device Contamination With Biological Material 1 1
Disconnection 1 1
Material Erosion 1 1
Material Rupture 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Solder Joint Fracture 1 1
No Apparent Adverse Event 1 1
Improper Flow or Infusion 1 1
Inadequate User Interface 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Difficult to Open or Close 1 1
Out-Of-Box Failure 1 1
Incomplete or Missing Packaging 1 1
Failure to Align 1 1
Melted 1 1
Migration or Expulsion of Device 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Burst Container or Vessel 1 1
Cap 1 1
Bent 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 256 256
No Clinical Signs, Symptoms or Conditions 91 91
No Known Impact Or Consequence To Patient 42 42
Not Applicable 29 29
No Code Available 20 20
Abscess 16 16
No Patient Involvement 14 14
Unspecified Infection 9 9
Foreign Body In Patient 8 8
Obstruction/Occlusion 7 7
Post Operative Wound Infection 7 7
Blood Loss 7 7
Seroma 6 6
Fever 6 6
Hematoma 5 5
Pain 5 5
Hernia 4 4
Sepsis 3 3
Inflammation 3 3
Failure to Anastomose 3 3
No Information 3 3
Device Embedded In Tissue or Plaque 2 2
Necrosis 2 2
Abdominal Pain 2 2
Adhesion(s) 2 2
Burn(s) 2 2
Insufficient Information 2 2
Peritonitis 2 2
Rupture 1 1
Wound Dehiscence 1 1
Perforation 1 1
Low Blood Pressure/ Hypotension 1 1
Bradycardia 1 1
Cellulitis 1 1
Purulent Discharge 1 1
Edema 1 1
Fistula 1 1
Bone Fracture(s) 1 1
Headache 1 1
Incontinence 1 1
Nausea 1 1
Tachycardia 1 1
Vomiting 1 1
Infection, Pyrogenic 1 1
Injury 1 1
Premature Labor 1 1
Thromboembolism 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Cardinal Health 200, LLC II Mar-09-2020
3 Genicon, Inc. II Jun-05-2020
4 MicroAire Surgical Instruments, LLC II Apr-05-2016
5 TeDan Surgical Innovations LLC II May-01-2020
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