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
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	23	23
Display or Visual Feedback Problem	9	9
Optical Problem	7	7
Detachment of Device or Device Component	6	6
No Display/Image	5	5
Obstruction of Flow	5	5
Mechanical Problem	4	4
Suction Failure	4	4
Material Integrity Problem	4	4
Erratic or Intermittent Display	4	4
Break	3	3
Poor Quality Image	3	3
Material Fragmentation	3	3
Insufficient Information	2	2
Product Quality Problem	2	2
Computer Software Problem	2	2
Fracture	2	2
Overheating of Device	2	2
Leak/Splash	1	1
Failure to Shut Off	1	1
Compatibility Problem	1	1
Physical Resistance/Sticking	1	1
Display Difficult to Read	1	1
Device Markings/Labelling Problem	1	1
Defective Component	1	1
Deflation Problem	1	1
Key or Button Unresponsive/not Working	1	1
Solder Joint Fracture	1	1
Material Separation	1	1
No Apparent Adverse Event	1	1
Excessive Heating	1	1
Melted	1	1
Connection Problem	1	1
Difficult to Open or Close	1	1
Loose or Intermittent Connection	1	1
Fluid/Blood Leak	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	50	50
Insufficient Information	16	16
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
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	Integra LifeSciences Corp.	II	Mar-06-2025
3	Integra LifeSciences Corp.	II	Jul-11-2024