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	3
HJY SMART MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	1
REBOUND THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	2
REBOUND THERAPEUTICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
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	31	31
Detachment of Device or Device Component	8	8
Break	7	7
Mechanical Problem	6	6
Poor Quality Image	4	4
Suction Failure	4	4
Material Integrity Problem	4	4
Obstruction of Flow	4	4
Complete Blockage	3	3
Optical Problem	3	3
Product Quality Problem	3	3
Communication or Transmission Problem	2	2
Material Twisted/Bent	2	2
Solder Joint Fracture	2	2
Material Separation	2	2
Fracture	2	2
Display or Visual Feedback Problem	2	2
Device-Device Incompatibility	1	1
Failure to Shut Off	1	1
No Display/Image	1	1
Physical Resistance/Sticking	1	1
Insufficient Information	1	1
Defective Component	1	1
Deflation Problem	1	1
Key or Button Unresponsive/not Working	1	1
Material Fragmentation	1	1
Device Difficult to Setup or Prepare	1	1
No Apparent Adverse Event	1	1
Erratic or Intermittent Display	1	1
Appropriate Term/Code Not Available	1	1
Excessive Heating	1	1
Melted	1	1
Suction Problem	1	1
Overheating of Device	1	1
Difficult to Open or Close	1	1
Misfocusing	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	30	30
Insufficient Information	15	15
Intracranial Hemorrhage	10	10
No Consequences Or Impact To Patient	10	10
Hemorrhage/Bleeding	7	7
No Known Impact Or Consequence To Patient	4	4
Foreign Body In Patient	4	4
Convulsion/Seizure	4	4
Brain Injury	2	2
Hematoma	2	2
Hydrocephalus	2	2
Device Embedded In Tissue or Plaque	2	2
Patient Problem/Medical Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Death	1	1
No Code Available	1	1
Respiratory Distress	1	1
Seizures	1	1
Inflammation	1	1
Hemorrhagic Stroke	1	1
Hemorrhage, Subdural	1	1
Hemorrhage, Intraventricular	1	1
Tissue Damage	1	1
Hemorrhage, Subarachnoid	1	1
Headache	1	1
Ischemia Stroke	1	1
Full thickness (Third Degree) Burn	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
4	Karl Storz Endoscopy	II	Mar-20-2020
5	Karl Storz Endoscopy	II	Aug-28-2019