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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, needle
Regulation Description Needle electrode.
Product CodeGXZ
Regulation Number 882.1350
Device Class 2


Premarket Reviews
ManufacturerDecision
SUZHOU HAISHEN MEDICAL DEVICE ASSOCIATES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TECHNOMED EUROPE
  SUBSTANTIALLY EQUIVALENT 1
TEDAN SURGICAL INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 9 9
2022 18 19
2023 21 21
2024 58 58
2025 76 76
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 64 64
False Negative Result 48 48
Detachment of Device or Device Component 29 29
Inappropriate Audible Prompt/Feedback 15 15
Use of Device Problem 9 10
Device Sensing Problem 8 8
Break 6 6
Failure to Sense 5 5
False Positive Result 5 5
Material Fragmentation 3 3
Unable to Obtain Readings 3 3
Connection Problem 3 3
Patient Device Interaction Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Unsafe to Use in Environment 2 2
Product Quality Problem 2 2
Material Separation 2 2
Electrical Shorting 2 2
Fracture 2 2
Device Dislodged or Dislocated 2 2
Difficult to Open or Close 2 2
Flaked 2 2
No Device Output 2 2
Signal Artifact/Noise 1 1
Device Slipped 1 1
Incomplete or Missing Packaging 1 1
Component Missing 1 1
Insufficient Device Problem Information 1 1
Defibrillation/Stimulation Problem 1 1
Overheating of Device 1 1
Intermittent Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 141 141
Foreign Body In Patient 30 30
Nerve Damage 9 10
Burn(s) 7 7
Needle Stick/Puncture 3 3
Insufficient Information 3 3
Device Embedded In Tissue or Plaque 3 3
Electric Shock 2 2
Paralysis 2 2
Discomfort 2 2
Partial thickness (Second Degree) Burn 2 2
Facial Paralysis 2 2
Inflammation 1 1
Perforation 1 1
Paresis 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Technomed Europe II Jan-07-2022
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