TPLC - Total Product Life Cycle

show TPLC since

Device	endoscope, neurological
Regulation Description	Neurological endoscope.
Definition	If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code	GWG
Regulation Number	882.1480
Device Class	2

Premarket Reviews
Manufacturer	Decision
CARL ZEISS MEDITEC, AG
	SUBSTANTIALLY EQUIVALENT	1
CLARUS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
CLEARMIND BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	2
HJY SMART MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
REBOUND THERAPEUTICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
VPIX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	24	24
Display or Visual Feedback Problem	9	9
Optical Problem	7	7
Detachment of Device or Device Component	6	6
Obstruction of Flow	5	5
No Display/Image	5	5
Erratic or Intermittent Display	4	4
Mechanical Problem	4	4
Material Integrity Problem	4	4
Suction Failure	4	4
No Apparent Adverse Event	3	3
Material Fragmentation	3	3
Poor Quality Image	3	3
Break	3	3
Computer Software Problem	2	2
Material Disintegration	2	2
Overheating of Device	2	2
Product Quality Problem	2	2
Insufficient Information	2	2
Fracture	2	2
Physical Resistance/Sticking	1	1
Unexpected Shutdown	1	1
Excessive Heating	1	1
Key or Button Unresponsive/not Working	1	1
Temperature Problem	1	1
Mechanical Jam	1	1
Connection Problem	1	1
Device Markings/Labelling Problem	1	1
Difficult to Open or Close	1	1
Failure to Shut Off	1	1
Compatibility Problem	1	1
Material Separation	1	1
Defective Component	1	1
Solder Joint Fracture	1	1
Leak/Splash	1	1
Loose or Intermittent Connection	1	1
Melted	1	1
Display Difficult to Read	1	1
Deflation Problem	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	51	51
Insufficient Information	18	18
Intracranial Hemorrhage	10	10
Convulsion/Seizure	4	4
Hemorrhage/Bleeding	4	4
Hydrocephalus	2	2
No Consequences Or Impact To Patient	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Vascular Dissection	1	1
Hematoma	1	1
Inflammation	1	1
Hemorrhagic Stroke	1	1
Perforation of Vessels	1	1
Headache	1	1
Full thickness (Third Degree) Burn	1	1
Device Embedded In Tissue or Plaque	1	1
Cerebral Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Implant Systems LLC	II	Sep-06-2023
2	Aesculap Inc	II	Mar-02-2026
3	Integra LifeSciences Corp.	II	Mar-06-2025
4	Integra LifeSciences Corp.	II	Jul-11-2024