TPLC - Total Product Life Cycle

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Device	gastroscope and accessories, flexible/rigid
Regulation Description	Endoscope and accessories.
Definition	To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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	FDS
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACTUATED MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	2
EVOENDO, INC.
	SUBSTANTIALLY EQUIVALENT	3
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	7
FUJIFILM CORPORATON
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
HUIZHOU XZING TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IQ ENDOSCOPES LIMITED
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEPTUNE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PENTAX OF AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Clean Adequately	16465	16476
Poor Quality Image	5494	5503
Device Reprocessing Problem	3867	3873
No Display/Image	3150	3151
Break	2519	2519
Communication or Transmission Problem	2496	2496
Erratic or Intermittent Display	2224	2224
Microbial Contamination of Device	2167	2168
Fluid/Blood Leak	2003	2003
Obstruction of Flow	1902	1903
Residue After Decontamination	1742	1742
Optical Obstruction	1032	1032
Contamination	1027	1034
Detachment of Device or Device Component	1021	1021
Thermal Decomposition of Device	712	712
Corroded	606	606
Contamination /Decontamination Problem	574	574
Melted	531	531
Device Contamination with Chemical or Other Material	511	511
Adverse Event Without Identified Device or Use Problem	502	504
Image Display Error/Artifact	416	417
Optical Distortion	348	348
Flare or Flash	332	332
Overheating of Device	324	324
Misfocusing	317	317
Display or Visual Feedback Problem	200	202
Unintended Movement	198	198
Crack	181	181
Material Split, Cut or Torn	179	179
Material Deformation	166	166
Degraded	144	144
Gas/Air Leak	132	132
Loose or Intermittent Connection	132	132
Component Missing	131	131
Peeled/Delaminated	111	112
Scratched Material	111	111
Material Discolored	96	96
Collapse	88	88
Partial Blockage	88	88
Optical Problem	87	87
Electrical /Electronic Property Problem	85	85
Mechanical Problem	84	84
Improper Flow or Infusion	84	84
Complete Blockage	80	80
Positioning Failure	77	77
Physical Resistance/Sticking	76	76
Dent in Material	75	75
Leak/Splash	74	74
Mechanical Jam	69	69
Excessive Heating	64	64

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	49365	49399
No Consequences Or Impact To Patient	381	381
Insufficient Information	285	285
Hemorrhage/Bleeding	225	227
Perforation	166	166
No Known Impact Or Consequence To Patient	160	160
Foreign Body In Patient	103	104
No Patient Involvement	77	77
Bacterial Infection	59	59
Unspecified Infection	52	52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	49	49
Fever	42	42
Drug Resistant Bacterial Infection	30	30
Gastrointestinal Hemorrhage	30	30
Bowel Perforation	27	27
Abdominal Pain	23	23
Pancreatitis	22	22
Unspecified Tissue Injury	21	21
Pain	20	20
Injury	19	19
Unspecified Hepatic or Biliary Problem	17	17
Peritonitis	16	16
Chest Pain	15	15
Stenosis	14	14
Laceration(s)	13	13
Sepsis	12	12
Pneumothorax	12	12
Unspecified Gastrointestinal Problem	11	11
Abscess	10	10
Pleural Effusion	8	8
Perforation of Esophagus	8	8
Fistula	8	8
Laceration(s) of Esophagus	8	8
Nausea	7	7
Pneumonia	7	7
Chills	7	7
Stenosis of the esophagus	7	7
Internal Organ Perforation	7	7
Malaise	7	7
Pulmonary Emphysema	7	7
Muscle/Tendon Damage	6	6
Swelling/ Edema	6	6
Abrasion	6	6
Unspecified Respiratory Problem	5	5
Aspiration Pneumonitis	5	5
Cardiac Arrest	5	5
Chemical Exposure	4	4
Pulmonary Embolism	4	4
Hematoma	4	4
Therapeutic Effects, Unexpected	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Aomori Olympus Co., Ltd.	II	Sep-07-2023
2	Olympus Corporation of the Americas	II	Dec-05-2024
3	Olympus Corporation of the Americas	II	Nov-20-2024
4	Olympus Corporation of the Americas	II	Jun-21-2022
5	Olympus Corporation of the Americas	II	Nov-27-2020