TPLC - Total Product Life Cycle

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Device	endoscope, neurological
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
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC AG
	SUBSTANTIALLY EQUIVALENT	3
CLARUS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
CLEARMIND BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	3
HJY SMART MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY AMERICA, INC
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY-AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
MAUNA KEA TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
MRI INTERVENTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	4
REBOUND THERAPEUTICS
	SUBSTANTIALLY EQUIVALENT	2
REBOUND THERAPEUTICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
VISIONSENSE, LTD.
	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	41	41
Leak/Splash	17	17
Break	17	17
Device Operates Differently Than Expected	14	14
Complete Blockage	12	12
Mechanical Problem	11	11
Detachment of Device or Device Component	9	9
Aspiration Issue	7	7
Poor Quality Image	6	6
Device Operational Issue	5	5
Out-Of-Box Failure	5	5
Obstruction of Flow	4	4
Suction Failure	4	4
Material Integrity Problem	4	4
Burst Container or Vessel	3	3
Fluid/Blood Leak	3	3
Product Quality Problem	3	3
Appropriate Term/Code Not Available	3	3
Fracture	3	3
Defective Device	3	3
Material Protrusion/Extrusion	3	3
Solder Joint Fracture	3	3
Image Resolution Poor	2	2
Difficult to Remove	2	2
Communication or Transmission Problem	2	2
Detachment Of Device Component	2	2
Pumping Problem	2	2
Overheating of Device	2	2
Vibration	2	2
Optical Problem	2	2
Display or Visual Feedback Problem	2	2
Bent	2	2
Material Separation	2	2
Failure to Conduct	2	2
Device Difficult to Setup or Prepare	2	2
Device Damaged Prior to Use	2	2
Material Twisted/Bent	2	2
Material Fragmentation	2	2
Date/Time-Related Software Problem	1	1
Material Deformation	1	1
Material Rupture	1	1
Device Handling Problem	1	1
Decrease in Suction	1	1
Key or Button Unresponsive/not Working	1	1
Inadequate User Interface	1	1
Arcing of Electrodes	1	1
Misfocusing	1	1
Loss of or Failure to Bond	1	1
Deflation Problem	1	1
Temperature Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	46	46
No Known Impact Or Consequence To Patient	46	46
No Clinical Signs, Symptoms or Conditions	23	23
No Patient Involvement	11	11
No Code Available	10	10
Intracranial Hemorrhage	10	10
Insufficient Information	9	9
Hemorrhage/Bleeding	8	8
Foreign Body In Patient	5	5
Device Embedded In Tissue or Plaque	3	3
Convulsion/Seizure	3	3
Brain Injury	3	3
Hydrocephalus	3	3
Hemorrhage, Intraventricular	2	2
Hematoma	2	2
Seizures	2	2
Death	2	2
Unspecified Infection	2	2
Hemorrhagic Stroke	1	1
Hemorrhage, Subdural	1	1
Fever	1	1
Edema	1	1
Seroma	1	1
Inflammation	1	1
No Information	1	1
Respiratory Distress	1	1
Hemorrhage, Cerebral	1	1
Abscess	1	1
Therapeutic Response, Decreased	1	1
Cerebrospinal Fluid Leakage	1	1
Tissue Damage	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Bacterial Infection	1	1
Patient Problem/Medical Problem	1	1
Therapeutic Effects, Unexpected	1	1
Meningitis	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	Aesculap Implant Systems LLC	II	Mar-20-2017
3	Geomed Medizin-Technik Gmbh & Co.	II	Feb-19-2012
4	Integra LifeSciences Corp.	II	Jul-11-2024
5	Karl Storz Endoscopy	II	Mar-20-2020
6	Karl Storz Endoscopy	II	Aug-28-2019
7	Mitaka USA, Inc.	II	May-11-2012
8	Visionsense, Ltd.	II	Mar-08-2012