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
RESNENT, LLC
	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	1672	1672
Fluid/Blood Leak	1227	1230
No Display/Image	637	637
Erratic or Intermittent Display	298	298
Optical Obstruction	268	268
Detachment of Device or Device Component	207	207
Failure to Clean Adequately	191	191
Device Reprocessing Problem	160	160
Optical Distortion	125	125
Poor Quality Image	70	70
Unintended Movement	66	66
Peeled/Delaminated	64	64
Material Split, Cut or Torn	60	60
Material Separation	40	40
Contamination	36	36
Crack	33	33
Corroded	29	29
Optical Problem	29	29
Microbial Contamination of Device	28	28
Degraded	27	27
Component Missing	27	27
Obstruction of Flow	19	19
Fracture	17	17
Mechanical Problem	17	17
Material Deformation	16	16
Loss of or Failure to Bond	14	14
Contamination /Decontamination Problem	14	14
Output Problem	14	14
Residue After Decontamination	14	14
Material Integrity Problem	12	12
Collapse	12	12
Insufficient Information	12	12
Adverse Event Without Identified Device or Use Problem	11	11
Overcorrection	11	11
Physical Resistance/Sticking	11	12
Use of Device Problem	10	10
Moisture Damage	10	13
Scratched Material	10	10
Device Fell	9	9
Optical Discoloration	9	9
Misfocusing	9	9
Dent in Material	8	8
Material Fragmentation	8	8
Overheating of Device	8	8
Device Contaminated at the User Facility	8	8
Gas/Air Leak	6	6
Positioning Failure	6	6
Electrical /Electronic Property Problem	6	6
Temperature Problem	5	5
Loose or Intermittent Connection	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5356	5360
Insufficient Information	42	42
No Consequences Or Impact To Patient	21	21
Burn(s)	17	17
No Patient Involvement	17	17
Foreign Body In Patient	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
No Known Impact Or Consequence To Patient	6	6
Discomfort	5	5
Injury	4	4
Anaphylactic Shock	4	4
Hemorrhage/Bleeding	4	4
Laceration(s)	3	3
Superficial (First Degree) Burn	2	2
Fever	2	2
Pain	2	2
Pneumonia	2	2
Unspecified Tissue Injury	2	2
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
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	Olympus Corporation of the Americas	II	Jun-08-2020
5	Shirakawa Olympus Co., Ltd.	II	Jan-09-2024