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
OLYMPUS CORPORATIONS OF THE AMERICAS
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
PROVERUM LIMITED
	SUBSTANTIALLY EQUIVALENT	1
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
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	22217	22220
Poor Quality Image	9104	9106
Communication or Transmission Problem	7924	7925
Erratic or Intermittent Display	2897	2897
Break	1948	1948
Leak/Splash	1839	1839
Output Problem	1702	1702
Connection Problem	1437	1438
Failure to Power Up	1433	1433
Material Split, Cut or Torn	1269	1269
Display or Visual Feedback Problem	1232	1232
Loose or Intermittent Connection	1126	1126
Electrical /Electronic Property Problem	1011	1011
Gas/Air Leak	961	961
Corroded	896	896
Detachment of Device or Device Component	660	660
Image Display Error/Artifact	639	640
No Device Output	510	510
Crack	502	502
Power Problem	471	471
Disconnection	423	423
Defective Component	407	407
Activation Failure	386	386
Key or Button Unresponsive/not Working	294	294
Circuit Failure	265	265
Failure to Clean Adequately	208	208
Loss of Power	207	207
Material Integrity Problem	204	204
Scratched Material	195	195
Degraded	193	193
Mechanical Problem	182	182
Material Deformation	180	180
Optical Problem	170	170
Material Puncture/Hole	161	161
Unexpected Shutdown	156	156
Material Twisted/Bent	149	149
Optical Discoloration	146	146
Intermittent Loss of Power	145	145
No Visual Prompts/Feedback	121	121
Image Orientation Incorrect	114	114
Unstable	104	104
Noise, Audible	103	103
Misfocusing	102	102
Fluid/Blood Leak	102	102
Peeled/Delaminated	97	97
Physical Resistance/Sticking	94	94
Incomplete or Inadequate Connection	94	94
Device Reprocessing Problem	88	88
Activation Problem	85	85
Moisture Damage	76	76

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	55854	55863
No Consequences Or Impact To Patient	490	490
No Patient Involvement	210	210
Insufficient Information	179	179
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	26	26
Hemorrhage/Blood Loss/Bleeding	19	19
Perforation	10	10
Burn(s)	8	8
Pneumothorax	8	8
Bowel Perforation	7	7
Superficial (First Degree) Burn	6	6
No Information	5	5
Laceration(s)	5	5
Pain	5	5
Pancreatitis	4	4
Foreign Body In Patient	3	3
Apnea	3	3
Unspecified Tissue Injury	3	3
Electric Shock	3	3
Pulmonary Emphysema	2	2
Partial thickness (Second Degree) Burn	2	2
Easy Bruising	2	2
Pneumoperitoneum	2	2
Bone Cement Implantation Syndrome	2	2
Respiratory Failure	2	2
Emotional Changes	1	1
Oversedation	1	1
Unspecified Hepatic or Biliary Problem	1	1
Patient Problem/Medical Problem	1	1
Full thickness (Third Degree) Burn	1	1
Cardiac Arrest	1	1
Confusion/ Disorientation	1	1
Low Oxygen Saturation	1	1
Unspecified Respiratory Problem	1	1
Cerebrospinal Fluid Leakage	1	1
Asystole	1	1
Respiratory Insufficiency	1	1
Dysphasia	1	1
Discomfort	1	1
Arrhythmia	1	1
Low Blood Pressure/ Hypotension	1	1
Perforation of Esophagus	1	1
Neck Pain	1	1
Abdominal Pain	1	1
Headache	1	1
Tissue Breakdown	1	1
Post Operative Wound Infection	1	1
Burning Sensation	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