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	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	1738	1738
Fluid/Blood Leak	1284	1287
No Display/Image	718	719
Detachment of Device or Device Component	344	344
Erratic or Intermittent Display	317	317
Optical Obstruction	282	282
Failure to Clean Adequately	277	277
Device Reprocessing Problem	204	204
Optical Distortion	125	125
Peeled/Delaminated	108	108
Poor Quality Image	84	84
Material Split, Cut or Torn	70	70
Unintended Movement	66	66
Corroded	64	64
Material Separation	59	59
Contamination	58	58
Degraded	49	49
Crack	40	40
Optical Problem	35	35
Component Missing	33	33
Microbial Contamination of Device	26	26
Loss of or Failure to Bond	25	25
Material Deformation	24	24
Contamination /Decontamination Problem	23	23
Residue After Decontamination	22	22
Obstruction of Flow	21	21
Mechanical Problem	21	21
Fracture	20	20
Display or Visual Feedback Problem	19	19
Moisture Damage	16	19
Material Integrity Problem	16	16
Output Problem	16	16
Physical Resistance/Sticking	14	15
Insufficient Information	13	13
Collapse	13	13
Scratched Material	13	13
Material Fragmentation	13	13
Overcorrection	11	11
Use of Device Problem	11	11
Dent in Material	11	11
Misfocusing	10	10
Optical Discoloration	9	9
Device Fell	9	9
Device Contaminated at the User Facility	9	9
Overheating of Device	8	8
Communication or Transmission Problem	8	8
Material Discolored	8	8
Gas/Air Leak	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	6072	6077
Insufficient Information	49	49
Burn(s)	17	17
Foreign Body In Patient	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
No Consequences Or Impact To Patient	6	6
Discomfort	5	5
Laceration(s)	5	5
Hemorrhage/Bleeding	3	3
Superficial (First Degree) Burn	2	2
No Patient Involvement	2	2
Pain	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