TPLC - Total Product Life Cycle

show TPLC since

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	2
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	1803	1803
Fluid/Blood Leak	1320	1323
No Display/Image	763	764
Detachment of Device or Device Component	514	514
Failure to Clean Adequately	371	371
Erratic or Intermittent Display	326	326
Optical Obstruction	288	288
Device Reprocessing Problem	250	250
Peeled/Delaminated	159	159
Optical Distortion	127	127
Corroded	125	125
Poor Quality Image	93	93
Material Split, Cut or Torn	80	80
Contamination	79	79
Material Separation	72	72
Degraded	71	71
Unintended Movement	66	66
Loss of or Failure to Bond	64	64
Material Fragmentation	56	56
Residue After Decontamination	52	52
Crack	52	52
Component Missing	39	39
Optical Problem	35	35
Contamination /Decontamination Problem	30	30
Material Deformation	29	29
Microbial Contamination of Device	26	26
Fracture	23	23
Obstruction of Flow	22	22
Mechanical Problem	21	21
Display or Visual Feedback Problem	20	20
Output Problem	19	19
Moisture Damage	19	22
Scratched Material	17	17
Material Integrity Problem	16	16
Collapse	14	14
Physical Resistance/Sticking	14	15
Insufficient Information	13	13
Dent in Material	11	11
Overcorrection	11	11
Device Fell	11	11
Use of Device Problem	11	11
Material Discolored	11	11
Loose or Intermittent Connection	10	10
Misfocusing	10	10
Gas/Air Leak	9	9
Optical Discoloration	9	9
Device Contaminated at the User Facility	9	9
Communication or Transmission Problem	9	9
Overheating of Device	8	8
Environmental Particulates	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6782	6787
Insufficient Information	51	51
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