TPLC - Total Product Life Cycle

• Device: electrode, needle
• Regulation Description: Needle electrode.
• Product Code: GXZ
• Regulation Number: 882.1350
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	58	58
False Negative Result	43	43
Detachment of Device or Device Component	29	29
Inappropriate Audible Prompt/Feedback	13	13
Use of Device Problem	8	9
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
Fracture	2	2
Device Dislodged or Dislocated	2	2
Difficult to Open or Close	2	2
Flaked	2	2
Signal Artifact/Noise	1	1
Device Slipped	1	1
Entrapment of Device	1	1
Incomplete or Missing Packaging	1	1
Physical Resistance/Sticking	1	1
Component Missing	1	1
Defibrillation/Stimulation Problem	1	1
Migration	1	1
Overheating of Device	1	1
Intermittent Loss of Power	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	127	127
Foreign Body In Patient	27	27
Nerve Damage	9	10
Burn(s)	5	5
Device Embedded In Tissue or Plaque	3	3
Paralysis	2	2
Needle Stick/Puncture	2	2
Discomfort	2	2
Insufficient Information	2	2
Partial thickness (Second Degree) Burn	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