TPLC - Total Product Life Cycle

• Device: electrode, cortical
• Product Code: GYC
• Regulation Number: 882.1310
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AD-TECH MEDICAL INSTRUMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BLACKROCK MICROSYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
BLACKROCK NEUROMED
	SUBSTANTIALLY EQUIVALENT	1
CHATTEN ASSOCIATES, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORTEC GMBH
	SUBSTANTIALLY EQUIVALENT	1
DIXI MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
G.TEC MEDICAL ENGINEERING GMBH
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MICROMED S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
NEUROONE, INC.
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORP.
	SUBSTANTIALLY EQUIVALENT	1
PMT CORP.
	SUBSTANTIALLY EQUIVALENT	1
SPES MEDICA SRL
	SUBSTANTIALLY EQUIVALENT	1
WISE S.R.L.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	14	14
2015	9	9
2016	2	2
2017	6	6
2018	3	3
2019	1	1
2020	1	1
2021	1	1
2022	2	2
2023	2	2
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	9	9
Device Operates Differently Than Expected	8	8
Break	6	6
Detachment Of Device Component	4	4
No Device Output	2	2
Display or Visual Feedback Problem	2	2
Output Problem	2	2
Defective Device	2	2
Improper Device Output	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Extrusion	1	1
Self-Activation or Keying	1	1
Residue After Decontamination	1	1
Therapeutic or Diagnostic Output Failure	1	1
Signal Artifact/Noise	1	1
Device Inoperable	1	1
Device Contaminated at the User Facility	1	1
Tear, Rip or Hole in Device Packaging	1	1
Failure to Read Input Signal	1	1
Low impedance	1	1
Device Contamination with Body Fluid	1	1
Issue With Displayed Error Message	1	1
Problem with Sterilization	1	1
Energy Output To Patient Tissue Incorrect	1	1
Material Twisted/Bent	1	1
Packaging Problem	1	1
Torn Material	1	1
Insufficient Information	1	1
Noise, Audible	1	1
No Audible Prompt/Feedback	1	1
Entrapment of Device	1	1
Device Alarm System	1	1
Impedance Problem	1	1
Material Protrusion/Extrusion	1	1
Out-Of-Box Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	20	20
No Consequences Or Impact To Patient	5	5
No Patient Involvement	4	4
Foreign Body In Patient	4	4
No Clinical Signs, Symptoms or Conditions	3	3
No Information	2	2
Injury	2	2
Tissue Damage	2	2
Weakness	1	1
Abscess	1	1
Bacterial Infection	1	1
Dysphagia/ Odynophagia	1	1
No Code Available	1	1
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ad-Tech Medical Instrument Corporation	II	Aug-28-2019
2	Ad-Tech Medical Instrument Corporation	I	Mar-02-2013
3	CareFusion 209 Inc.	I	Jan-26-2012
4	Integra Burlington MA, Inc.	II	Apr-01-2013