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	2427	2428
Electrical /Electronic Property Problem	1092	1092
No Display/Image	799	799
Failure to Power Up	543	543
Output Problem	542	542
Poor Quality Image	475	475
No Device Output	422	422
Display or Visual Feedback Problem	351	351
No Visual Prompts/Feedback	330	330
Break	320	320
Power Problem	212	212
Connection Problem	193	193
Defective Component	171	171
Erratic or Intermittent Display	157	157
Optical Problem	151	151
Image Display Error/Artifact	117	117
Key or Button Unresponsive/not Working	106	106
Mechanical Problem	93	93
Loose or Intermittent Connection	85	85
Leak/Splash	78	78
Loss of Power	66	66
Overheating of Device	62	62
Intermittent Loss of Power	58	58
Defective Device	55	55
Detachment of Device or Device Component	49	49
Electrical Power Problem	48	48
Physical Resistance/Sticking	41	41
Unexpected Shutdown	38	38
Corroded	33	33
Temperature Problem	31	31
Noise, Audible	30	30
Crack	28	28
Fluid/Blood Leak	28	28
Energy Output Problem	23	23
Flare or Flash	21	21
Mechanical Jam	20	20
Material Integrity Problem	20	20
Failure to Clean Adequately	19	19
Intermittent Communication Failure	19	19
Application Program Problem	19	19
Use of Device Problem	17	17
Component Missing	17	17
Fracture	17	17
Device Alarm System	16	16
Appropriate Term/Code Not Available	16	16
Material Split, Cut or Torn	15	15
Moisture Damage	14	14
Contamination	13	13
Adverse Event Without Identified Device or Use Problem	13	13
Smoking	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7864	7865
No Consequences Or Impact To Patient	737	737
No Patient Involvement	296	296
No Known Impact Or Consequence To Patient	31	31
Foreign Body In Patient	21	21
Insufficient Information	11	11
Perforation	9	9
Burn(s)	9	9
Unspecified Tissue Injury	5	5
Patient Problem/Medical Problem	4	4
Dysuria	4	4
Fever	4	4
Urinary Tract Infection	4	4
Electric Shock	3	3
Device Embedded In Tissue or Plaque	3	3
Superficial (First Degree) Burn	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Adult Respiratory Distress Syndrome	2	2
Perforation of Esophagus	2	2
No Information	2	2
Aspiration/Inhalation	2	2
Injury	2	2
Cough	2	2
Partial thickness (Second Degree) Burn	2	2
Hemorrhage/Bleeding	2	2
Airway Obstruction	2	2
Abdominal Pain	1	1
Arrhythmia	1	1
Sepsis	1	1
Bowel Perforation	1	1
Abdominal Distention	1	1
Bowel Burn	1	1
Rupture	1	1
Burn, Thermal	1	1
Blister	1	1
Discomfort	1	1
Pain	1	1
Unspecified Hepatic or Biliary Problem	1	1
Unspecified Respiratory Problem	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