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
GRUMPY INNOVATION, INC.
	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	1585	1585
Fluid/Blood Leak	1156	1156
No Display/Image	536	536
Erratic or Intermittent Display	279	279
Optical Obstruction	247	247
Detachment of Device or Device Component	148	148
Optical Distortion	122	122
Failure to Clean Adequately	119	119
Device Reprocessing Problem	113	113
Unintended Movement	64	64
Peeled/Delaminated	48	48
Material Split, Cut or Torn	42	42
Poor Quality Image	38	38
Crack	26	26
Contamination	25	25
Material Separation	23	23
Microbial Contamination of Device	22	22
Obstruction of Flow	19	19
Optical Problem	18	18
Component Missing	17	17
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
Output Problem	9	9
Scratched Material	9	9
Material Integrity Problem	9	9
Optical Discoloration	8	8
Contamination /Decontamination Problem	8	8
Misfocusing	8	8
Physical Resistance/Sticking	7	7
Material Fragmentation	7	7
Material Deformation	7	7
Overheating of Device	6	6
Device Fell	6	6
Display or Visual Feedback Problem	5	5
Use of Device Problem	5	5
Device Contaminated at the User Facility	5	5
Moisture Damage	5	5
Gas/Air Leak	4	4
Defective Device	4	4
Defective Component	4	4
Loose or Intermittent Connection	4	4
Fitting Problem	4	4
Excessive Heating	3	3
Unsealed Device Packaging	3	3
Naturally Worn	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4707	4707
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