TPLC - Total Product Life Cycle

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Device	endoscope, accessories, narrow band spectrum
Regulation Description	Endoscope and accessories.
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	3433	3435
No Display/Image	1366	1369
Poor Quality Image	1061	1063
Electrical /Electronic Property Problem	964	965
Output Problem	918	918
No Device Output	607	607
Failure to Power Up	565	565
Display or Visual Feedback Problem	406	406
No Visual Prompts/Feedback	404	404
Break	402	402
Activation Failure	302	302
Connection Problem	289	289
Erratic or Intermittent Display	278	279
Power Problem	227	227
Optical Problem	198	198
Leak/Splash	174	174
Key or Button Unresponsive/not Working	170	170
Defective Component	166	166
Loose or Intermittent Connection	121	121
Image Display Error/Artifact	120	120
Failure to Clean Adequately	114	114
Corroded	109	109
Mechanical Problem	106	107
Activation Problem	91	91
Overheating of Device	78	78
Intermittent Loss of Power	72	72
Physical Resistance/Sticking	68	68
Loss of Power	64	64
Unexpected Shutdown	59	59
Detachment of Device or Device Component	58	58
Crack	55	55
Dent in Material	53	53
Material Split, Cut or Torn	47	47
Material Integrity Problem	46	46
Electrical Power Problem	46	46
Degraded	42	42
Moisture Damage	40	40
Fracture	38	38
Noise, Audible	35	35
Gas/Air Leak	35	35
Environmental Particulates	34	34
Temperature Problem	33	33
Mechanical Jam	33	33
Contamination	32	32
Intermittent Communication Failure	32	32
Defective Device	32	32
Fluid/Blood Leak	32	32
Flare or Flash	30	30
Material Deformation	25	25
Moisture or Humidity Problem	22	22

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	12422	12432
No Consequences Or Impact To Patient	187	187
No Patient Involvement	59	59
Foreign Body In Patient	25	30
Insufficient Information	24	27
Perforation	6	6
Cough	5	5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Burn(s)	5	5
Unspecified Tissue Injury	5	5
Fever	4	4
Urinary Tract Infection	4	4
Dysuria	4	4
Airway Obstruction	3	3
Device Embedded In Tissue or Plaque	3	3
Aspiration/Inhalation	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Adult Respiratory Distress Syndrome	2	2
Partial thickness (Second Degree) Burn	2	2
Perforation of Esophagus	2	2
Unspecified Infection	2	2
Laceration(s)	2	2
Pain	2	2
Superficial (First Degree) Burn	2	2
Low Oxygen Saturation	1	1
Asystole	1	1
Rupture	1	1
Full thickness (Third Degree) Burn	1	1
Patient Problem/Medical Problem	1	1
Unspecified Hepatic or Biliary Problem	1	1
Discomfort	1	1
Sepsis	1	1
No Information	1	1
Abdominal Pain	1	1
Blister	1	1
Unspecified Respiratory Problem	1	1
Biliary Leak	1	1
Arrhythmia	1	1
Cardiac Arrest	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aizu Olympus Co., Ltd.	II	Nov-17-2023
2	Olympus Corporation of the Americas	II	Jun-05-2025
3	Olympus Corporation of the Americas	II	Feb-29-2024
4	Olympus Corporation of the Americas	I	Nov-09-2023
5	Olympus Corporation of the Americas	II	Feb-13-2023
6	Olympus Corporation of the Americas	II	May-19-2022