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	2
PENTAX OF AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
RESNENT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	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	1820	1820
Fluid/Blood Leak	1326	1326
No Display/Image	782	783
Detachment of Device or Device Component	578	578
Failure to Clean Adequately	400	400
Erratic or Intermittent Display	330	330
Optical Obstruction	293	293
Device Reprocessing Problem	255	255
Peeled/Delaminated	186	186
Corroded	142	142
Optical Distortion	127	127
Poor Quality Image	95	95
Material Split, Cut or Torn	87	87
Contamination	85	85
Material Separation	78	78
Degraded	75	75
Crack	70	70
Loss of or Failure to Bond	69	69
Unintended Movement	66	66
Material Fragmentation	65	65
Residue After Decontamination	57	57
Component Missing	39	39
Optical Problem	35	35
Contamination /Decontamination Problem	31	31
Material Deformation	30	30
Microbial Contamination of Device	27	27
Fracture	24	24
Obstruction of Flow	22	22
Mechanical Problem	21	21
Display or Visual Feedback Problem	20	20
Output Problem	20	20
Moisture Damage	20	20
Scratched Material	17	17
Material Integrity Problem	16	16
Collapse	14	14
Physical Resistance/Sticking	14	15
Material Discolored	13	13
Insufficient Device Problem Information	13	13
Dent in Material	11	11
Overcorrection	11	11
Use of Device Problem	11	11
Loose or Intermittent Connection	11	11
Device Fell	11	11
Communication or Transmission Problem	10	10
Misfocusing	10	10
Device Contaminated at the User Facility	9	9
Gas/Air Leak	9	9
Optical Discoloration	9	9
Positioning Failure	8	8
Overheating of Device	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7025	7030
Insufficient Information	51	51
Burn(s)	17	17
Foreign Body In Patient	8	8
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	7	7
No Consequences Or Impact To Patient	6	6
Discomfort	5	5
Laceration(s)	5	5
Hemorrhage/Blood Loss/Bleeding	5	5
Pain	3	3
Pneumothorax	3	3
Aspiration/Inhalation	2	2
Respiratory Insufficiency	2	2
Superficial (First Degree) Burn	2	2
Unspecified Tissue Injury	2	2
No Patient Involvement	2	2
Fever	1	1
Lethargy	1	1
Hypersensitivity/Allergic reaction	1	1
Pleural Effusion	1	1
Pneumonia	1	1
Low Oxygen Saturation	1	1
Perforation	1	1
Transmissible Spongiform Encephalopathy(TSE)	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