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	1
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 MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	17627	17627
Poor Quality Image	5076	5076
Communication or Transmission Problem	4946	4946
Erratic or Intermittent Display	1798	1798
Break	1254	1254
Failure to Power Up	1242	1242
Electrical /Electronic Property Problem	1121	1121
Output Problem	864	864
Display or Visual Feedback Problem	832	832
Material Split, Cut or Torn	817	817
Connection Problem	799	799
Leak/Splash	689	689
Loose or Intermittent Connection	594	594
Image Display Error/Artifact	542	542
Power Problem	428	428
Corroded	398	398
Defective Component	344	344
No Device Output	328	328
Crack	328	328
Gas/Air Leak	291	291
Detachment of Device or Device Component	284	284
Disconnection	203	203
Loss of Power	192	192
Key or Button Unresponsive/not Working	153	153
Mechanical Problem	133	133
Circuit Failure	130	130
Material Twisted/Bent	127	127
Intermittent Loss of Power	112	112
Material Integrity Problem	109	109
Image Orientation Incorrect	96	96
Material Puncture/Hole	96	96
Optical Problem	93	93
No Visual Prompts/Feedback	91	91
Material Deformation	87	87
Fluid/Blood Leak	83	83
Scratched Material	82	82
Unexpected Shutdown	78	78
Defective Device	74	74
Noise, Audible	67	67
Device Reprocessing Problem	66	66
Optical Discoloration	64	64
Physical Resistance/Sticking	62	62
Signal Artifact/Noise	51	51
Fracture	51	51
Misfocusing	50	50
Contamination	50	50
Degraded	49	49
Failure to Clean Adequately	48	48
Peeled/Delaminated	45	45
Application Program Problem	43	43

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	34827	34827
No Consequences Or Impact To Patient	2533	2533
No Patient Involvement	1079	1079
No Known Impact Or Consequence To Patient	114	114
Insufficient Information	69	69
Hemorrhage/Bleeding	18	18
No Information	13	13
Perforation	10	10
Patient Problem/Medical Problem	9	9
Pneumothorax	7	7
Superficial (First Degree) Burn	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Pain	5	5
Pancreatitis	4	4
Burn(s)	4	4
Apnea	3	3
No Code Available	3	3
Bowel Perforation	3	3
Laceration(s)	3	3
Electric Shock	2	2
Respiratory Failure	2	2
Low Blood Pressure/ Hypotension	2	2
Blood Loss	2	2
Easy Bruising	2	2
Injury	2	2
Foreign Body In Patient	2	2
Partial thickness (Second Degree) Burn	2	2
Full thickness (Third Degree) Burn	1	1
Tissue Breakdown	1	1
Headache	1	1
Unspecified Respiratory Problem	1	1
Cerebrospinal Fluid Leakage	1	1
Unspecified Tissue Injury	1	1
Unspecified Hepatic or Biliary Problem	1	1
Discomfort	1	1
Burning Sensation	1	1
Oversedation	1	1
Post Operative Wound Infection	1	1
Burn, Thermal	1	1
Ischemia	1	1
Inflammation	1	1
Pulmonary Emphysema	1	1
Emotional Changes	1	1
Death	1	1
Arrhythmia	1	1
Abdominal Pain	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