TPLC - Total Product Life Cycle

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Device	endoscope, accessories, narrow band spectrum
Definition	Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.
Product Code	NWB
Regulation Number	876.1500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Communication or Transmission Problem	2379	2380
Electrical /Electronic Property Problem	1089	1089
No Display/Image	760	760
Failure to Power Up	540	540
Output Problem	527	527
Poor Quality Image	438	438
No Device Output	414	414
Display or Visual Feedback Problem	345	345
No Visual Prompts/Feedback	324	324
Break	294	294
Power Problem	210	210
Connection Problem	192	192
Defective Component	171	171
Optical Problem	146	146
Erratic or Intermittent Display	146	146
Image Display Error/Artifact	112	112
Key or Button Unresponsive/not Working	101	101
Mechanical Problem	91	91
Loose or Intermittent Connection	81	81
Leak/Splash	75	75
Loss of Power	65	65
Overheating of Device	62	62
Intermittent Loss of Power	57	57
Defective Device	55	55
Detachment of Device or Device Component	49	49
Electrical Power Problem	47	47
Physical Resistance/Sticking	40	40
Unexpected Shutdown	37	37
Corroded	33	33
Temperature Problem	31	31
Noise, Audible	30	30
Fluid/Blood Leak	28	28
Crack	27	27
Flare or Flash	21	21
Energy Output Problem	21	21
Mechanical Jam	20	20
Material Integrity Problem	19	19
Application Program Problem	19	19
Intermittent Communication Failure	18	18
Failure to Clean Adequately	18	18
Component Missing	18	18
Use of Device Problem	17	17
Appropriate Term/Code Not Available	16	16
Device Alarm System	16	16
Moisture Damage	14	14
Adverse Event Without Identified Device or Use Problem	14	14
Contamination	12	12
Thermal Decomposition of Device	12	12
Excessive Heating	11	11
Output below Specifications	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7633	7634
No Consequences Or Impact To Patient	738	738
No Patient Involvement	296	296
No Known Impact Or Consequence To Patient	34	34
Foreign Body In Patient	22	22
Insufficient Information	10	10
Perforation	9	9
Burn(s)	9	9
Unspecified Tissue Injury	5	5
Patient Problem/Medical Problem	4	4
Urinary Tract Infection	4	4
Dysuria	4	4
Fever	4	4
Device Embedded In Tissue or Plaque	3	3
Electric Shock	3	3
Injury	3	3
Airway Obstruction	2	2
Hemorrhage/Bleeding	2	2
Partial thickness (Second Degree) Burn	2	2
Cough	2	2
Aspiration/Inhalation	2	2
No Information	2	2
Perforation of Esophagus	2	2
Adult Respiratory Distress Syndrome	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Superficial (First Degree) Burn	2	2
Blister	1	1
Burn, Thermal	1	1
Rupture	1	1
Bowel Burn	1	1
Abdominal Distention	1	1
Bowel Perforation	1	1
Discomfort	1	1
Pain	1	1
Unspecified Hepatic or Biliary Problem	1	1
Sepsis	1	1
Unspecified Respiratory Problem	1	1
Arrhythmia	1	1
Unspecified Infection	1	1
Abdominal Pain	1	1
Full thickness (Third Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aizu Olympus Co., Ltd.	II	Nov-17-2023
2	Olympus Corporation of the Americas	II	Feb-29-2024
3	Olympus Corporation of the Americas	I	Nov-09-2023
4	Olympus Corporation of the Americas	II	Feb-13-2023
5	Olympus Corporation of the Americas	II	May-19-2022
6	Olympus Corporation of the Americas	II	Mar-12-2019