TPLC - Total Product Life Cycle

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Device	nasopharyngoscope (flexible or rigid)
Regulation Description	Nasopharyngoscope (flexible or rigid) and accessories.
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	EOB
Regulation Number	874.4760
Device Class	2

Premarket Reviews
Manufacturer	Decision
3NT MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	2
ATMOS MEDIZINTECHNIK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
H&A MUI ENTERPRISES INC.
	SUBSTANTIALLY EQUIVALENT	1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
KARL STORZ ENDOSCOPY - AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ SE & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
MEDICALTEK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDIMAGING INTEGRATED SOLUTION INC. (MIIS)
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OPTIM, LLC
	SUBSTANTIALLY EQUIVALENT	1
PENTAX OF AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZSQUARE, LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1568	1568
Fluid/Blood Leak	1144	1144
No Display/Image	524	524
Erratic or Intermittent Display	275	275
Optical Obstruction	245	245
Detachment of Device or Device Component	147	147
Optical Distortion	121	121
Failure to Clean Adequately	117	117
Device Reprocessing Problem	113	113
Unintended Movement	64	64
Peeled/Delaminated	48	48
Material Split, Cut or Torn	40	40
Poor Quality Image	37	37
Contamination	25	25
Crack	25	25
Material Separation	23	23
Microbial Contamination of Device	22	22
Obstruction of Flow	18	18
Component Missing	17	17
Optical Problem	16	16
Mechanical Problem	15	15
Fracture	14	14
Degraded	11	11
Insufficient Information	11	11
Overcorrection	11	11
Collapse	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Material Integrity Problem	9	9
Optical Discoloration	8	8
Output Problem	8	8
Contamination /Decontamination Problem	8	8
Scratched Material	8	8
Physical Resistance/Sticking	7	7
Misfocusing	7	7
Material Fragmentation	7	7
Overheating of Device	6	6
Display or Visual Feedback Problem	6	6
Device Fell	6	6
Material Deformation	6	6
Use of Device Problem	5	5
Moisture Damage	5	5
Defective Component	4	4
Defective Device	4	4
Loose or Intermittent Connection	4	4
Device Contaminated at the User Facility	4	4
Fitting Problem	4	4
Gas/Air Leak	3	3
Backflow	3	3
Delivered as Unsterile Product	3	3
Material Perforation	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4648	4648
Insufficient Information	33	33
No Consequences Or Impact To Patient	21	21
No Patient Involvement	17	17
Burn(s)	13	13
No Known Impact Or Consequence To Patient	6	6
Discomfort	5	5
Injury	4	4
Foreign Body In Patient	4	4
Anaphylactic Shock	4	4
Hemorrhage/Bleeding	4	4
Superficial (First Degree) Burn	2	2
Fever	2	2
Laceration(s)	2	2
Pain	2	2
Pneumonia	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Pneumothorax	1	1
No Code Available	1	1
Transmissible Spongiform Encephalopathy(TSE)	1	1
Perforation	1	1
Burn, Thermal	1	1
Exposure to Body Fluids	1	1
Pleural Effusion	1	1
Paresis	1	1
Unspecified Tissue Injury	1	1
Low Oxygen Saturation	1	1
Device Embedded In Tissue or Plaque	1	1
Decreased Appetite	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Karl Storz Endoscopy	II	May-10-2022
2	Olympus Corporation of the Americas	II	May-23-2024
3	Olympus Corporation of the Americas	II	Mar-22-2024
4	Olympus Corporation of the Americas	II	Jun-08-2020
5	Shirakawa Olympus Co., Ltd.	II	Jan-09-2024