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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
Regulation Description Manual gastroenterology-urology surgical instrument and accessories.
Product CodeFHQ
Regulation Number 876.4730
Device Class 1

MDR Year MDR Reports MDR Events
2021 57 57
2022 64 64
2023 63 63
2024 69 69
2025 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 108 108
Retraction Problem 76 76
Use of Device Problem 64 64
Misfire 38 38
Adverse Event Without Identified Device or Use Problem 23 23
Mechanical Problem 19 19
Break 16 16
Device-Device Incompatibility 14 14
Difficult to Open or Close 10 10
Defective Device 6 6
Failure to Align 5 5
Material Twisted/Bent 2 2
Entrapment of Device 1 1
Unsealed Device Packaging 1 1
Defective Component 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination 1 1
Material Fragmentation 1 1
Material Deformation 1 1
Packaging Problem 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Activation Failure 1 1
Appropriate Term/Code Not Available 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 208 208
Foreign Body In Patient 42 42
Insufficient Information 13 13
Hemorrhage/Bleeding 4 4
Device Embedded In Tissue or Plaque 3 3
Hematoma 2 2
Pain 2 2
No Consequences Or Impact To Patient 2 2
Discomfort 1 1
Dyspareunia 1 1
Abscess 1 1
Unspecified Tissue Injury 1 1
Erosion 1 1
Constipation 1 1

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