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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device holder, needle, gastroenterologic
Product CodeFHQ
Regulation Number 876.4730
Device Class 1

MDR Year MDR Reports MDR Events
2019 80 80
2020 50 50
2021 57 57
2022 64 64
2023 63 63
2024 72 72

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 177 177
Retraction Problem 112 112
Use of Device Problem 71 71
Misfire 43 43
Break 26 26
Mechanical Problem 23 23
Adverse Event Without Identified Device or Use Problem 23 23
Device-Device Incompatibility 18 18
Difficult to Open or Close 11 11
Failure to Align 5 5
Material Twisted/Bent 4 4
Defective Device 3 3
Therapeutic or Diagnostic Output Failure 3 3
Contamination 3 3
Material Separation 2 2
Fracture 2 2
Appropriate Term/Code Not Available 2 2
Material Frayed 1 1
Entrapment of Device 1 1
Difficult to Advance 1 1
Device Fell 1 1
Unsealed Device Packaging 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Difficult to Remove 1 1
Material Fragmentation 1 1
Material Deformation 1 1
Packaging Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Activation Failure 1 1
Suction Problem 1 1
Failure of Device to Self-Test 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 200 200
No Consequences Or Impact To Patient 62 62
Foreign Body In Patient 41 41
Device Embedded In Tissue or Plaque 38 38
No Known Impact Or Consequence To Patient 31 31
Insufficient Information 13 13
Pain 4 4
Hemorrhage/Bleeding 4 4
No Code Available 3 3
Hematoma 2 2
No Information 1 1
No Patient Involvement 1 1
Dyspareunia 1 1
Discomfort 1 1
Abscess 1 1
Unspecified Tissue Injury 1 1
Erosion 1 1
Constipation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boss Instruments, Ltd. II Aug-05-2020
2 Dufner Instrumente GmbH II Jul-10-2020
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