TPLC - Total Product Life Cycle

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Device	endoscopic video imaging system/component, gastroenterology-urology
Regulation Description	Endoscope and accessories.
Definition	To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Product Code	FET
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY-AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS CORPORATIONS OF THE AMERICAS
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
PROVERUM LIMITED
	SUBSTANTIALLY EQUIVALENT	1
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SOPHWAY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNIVLABS TECHNOLOGIES PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	23119	23122
Poor Quality Image	8682	8684
Communication or Transmission Problem	7606	7607
Erratic or Intermittent Display	2820	2820
Break	1968	1968
Output Problem	1656	1656
Leak/Splash	1648	1648
Failure to Power Up	1567	1567
Connection Problem	1386	1387
Display or Visual Feedback Problem	1235	1235
Material Split, Cut or Torn	1206	1206
Electrical /Electronic Property Problem	1195	1195
Loose or Intermittent Connection	1041	1041
Corroded	789	789
Gas/Air Leak	777	777
Image Display Error/Artifact	687	688
Detachment of Device or Device Component	602	602
Power Problem	537	537
No Device Output	496	496
Crack	479	479
Defective Component	426	426
Disconnection	396	396
Activation Failure	333	333
Key or Button Unresponsive/not Working	262	262
Circuit Failure	256	256
Loss of Power	208	208
Material Integrity Problem	197	197
Mechanical Problem	184	184
Optical Problem	172	172
Failure to Clean Adequately	171	171
Material Deformation	170	170
Scratched Material	168	168
Degraded	167	167
Material Twisted/Bent	159	159
Material Puncture/Hole	157	157
Unexpected Shutdown	145	145
Intermittent Loss of Power	144	144
Optical Discoloration	124	124
No Visual Prompts/Feedback	117	117
Image Orientation Incorrect	114	114
Fluid/Blood Leak	102	102
Defective Device	101	101
Noise, Audible	100	100
Physical Resistance/Sticking	90	90
Misfocusing	89	89
Device Reprocessing Problem	88	88
Peeled/Delaminated	87	87
Unstable	85	85
Incomplete or Inadequate Connection	82	82
Activation Problem	75	75

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	52721	52730
No Consequences Or Impact To Patient	2533	2533
No Patient Involvement	1079	1079
Insufficient Information	172	172
No Known Impact Or Consequence To Patient	114	114
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	25	25
Hemorrhage/Bleeding	21	21
No Information	13	13
Perforation	10	10
Patient Problem/Medical Problem	9	9
Pneumothorax	8	8
Burn(s)	8	8
Bowel Perforation	7	7
Superficial (First Degree) Burn	6	6
Pain	5	5
Laceration(s)	5	5
Pancreatitis	4	4
Apnea	3	3
No Code Available	3	3
Foreign Body In Patient	3	3
Unspecified Tissue Injury	3	3
Electric Shock	2	2
Respiratory Failure	2	2
Low Blood Pressure/ Hypotension	2	2
Pulmonary Emphysema	2	2
Blood Loss	2	2
Easy Bruising	2	2
Partial thickness (Second Degree) Burn	2	2
Injury	2	2
Full thickness (Third Degree) Burn	1	1
Tissue Breakdown	1	1
Low Oxygen Saturation	1	1
Respiratory Insufficiency	1	1
Headache	1	1
Unspecified Respiratory Problem	1	1
Cerebrospinal Fluid Leakage	1	1
Asystole	1	1
Unspecified Hepatic or Biliary Problem	1	1
Discomfort	1	1
Neck Pain	1	1
Burning Sensation	1	1
Oversedation	1	1
Confusion/ Disorientation	1	1
Post Operative Wound Infection	1	1
Cardiac Arrest	1	1
Burn, Thermal	1	1
Ischemia	1	1
Inflammation	1	1
Perforation of Esophagus	1	1
Emotional Changes	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aizu Olympus Co., Ltd.	II	Nov-17-2023
2	Olympus Corporation of the Americas	II	Oct-23-2024