TPLC - Total Product Life Cycle

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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 ENDOSCOPY
	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
Erratic or Intermittent Display	4	4
No Display/Image	4	4
Suction Failure	4	4
Mechanical Problem	4	4
Material Integrity Problem	4	4
No Apparent Adverse Event	4	4
Break	3	3
Material Fragmentation	3	3
Poor Quality Image	3	3
Computer Software Problem	2	2
Material Disintegration	2	2
Fracture	2	2
Product Quality Problem	2	2
Insufficient Device Problem Information	2	2
Deflation Problem	1	1
Display Difficult to Read	1	1
Fluid/Blood Leak	1	1
Defective Component	1	1
Solder Joint Fracture	1	1
Excessive Heating	1	1
Leak/Splash	1	1
Loose or Intermittent Connection	1	1
Melted	1	1
Overheating of Device	1	1
Material Separation	1	1
Compatibility Problem	1	1
Mechanical Jam	1	1
Temperature Problem	1	1
Physical Resistance/Sticking	1	1
Unexpected Shutdown	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
Hemorrhage/Blood Loss/Bleeding	4	4
Convulsion/Seizure	4	4
No Consequences Or Impact To Patient	2	2
Hydrocephalus	2	2
Headache	1	1
Full thickness (Third Degree) Burn	1	1
Hematoma	1	1
Inflammation	1	1
Device Embedded In Tissue or Plaque	1	1
Vascular Dissection	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Cerebral Edema	1	1
Perforation of Vessels	1	1
Hemorrhagic Stroke	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