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	1
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
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	2
OPTIM, LLC
	SUBSTANTIALLY EQUIVALENT	1
PENTAX OF AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
RESNENT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUHAI WESEE MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZSQUARE, LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1777	1777
Fluid/Blood Leak	1306	1309
No Display/Image	737	738
Detachment of Device or Device Component	426	426
Failure to Clean Adequately	338	338
Erratic or Intermittent Display	324	324
Optical Obstruction	285	285
Device Reprocessing Problem	233	233
Peeled/Delaminated	138	138
Optical Distortion	126	126
Corroded	98	98
Poor Quality Image	86	86
Material Split, Cut or Torn	72	72
Contamination	71	71
Unintended Movement	66	66
Material Separation	63	63
Degraded	62	62
Crack	47	47
Loss of or Failure to Bond	38	38
Component Missing	37	37
Optical Problem	35	35
Residue After Decontamination	33	33
Contamination /Decontamination Problem	27	27
Material Deformation	27	27
Microbial Contamination of Device	26	26
Fracture	22	22
Mechanical Problem	21	21
Obstruction of Flow	21	21
Display or Visual Feedback Problem	20	20
Moisture Damage	19	22
Material Fragmentation	18	18
Output Problem	18	18
Material Integrity Problem	16	16
Scratched Material	16	16
Physical Resistance/Sticking	14	15
Insufficient Information	13	13
Collapse	13	13
Use of Device Problem	11	11
Device Fell	11	11
Overcorrection	11	11
Dent in Material	11	11
Misfocusing	10	10
Material Discolored	9	9
Communication or Transmission Problem	9	9
Optical Discoloration	9	9
Device Contaminated at the User Facility	9	9
Gas/Air Leak	8	8
Overheating of Device	8	8
Loose or Intermittent Connection	7	7
Positioning Failure	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6442	6447
Insufficient Information	49	49
Burn(s)	17	17
Foreign Body In Patient	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
No Consequences Or Impact To Patient	6	6
Discomfort	5	5
Laceration(s)	5	5
Pain	3	3
Hemorrhage/Bleeding	3	3
Superficial (First Degree) Burn	2	2
No Patient Involvement	2	2
Unspecified Tissue Injury	2	2
Hypersensitivity/Allergic reaction	1	1
Pneumothorax	1	1
Transmissible Spongiform Encephalopathy(TSE)	1	1
Perforation	1	1
Fever	1	1
Pleural Effusion	1	1
Pneumonia	1	1
Low Oxygen Saturation	1	1
Lethargy	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	Shirakawa Olympus Co., Ltd.	II	Jan-09-2024