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	2576	2577
Electrical /Electronic Property Problem	1104	1104
No Display/Image	894	894
Output Problem	566	566
Failure to Power Up	560	560
Poor Quality Image	536	536
No Device Output	449	449
Display or Visual Feedback Problem	365	365
No Visual Prompts/Feedback	345	345
Break	336	336
Power Problem	214	214
Connection Problem	204	204
Defective Component	172	172
Erratic or Intermittent Display	168	168
Optical Problem	159	159
Image Display Error/Artifact	120	120
Key or Button Unresponsive/not Working	111	111
Mechanical Problem	95	95
Loose or Intermittent Connection	93	93
Leak/Splash	88	88
Loss of Power	67	67
Intermittent Loss of Power	64	64
Overheating of Device	62	62
Defective Device	55	55
Detachment of Device or Device Component	52	52
Electrical Power Problem	48	48
Physical Resistance/Sticking	44	44
Unexpected Shutdown	40	40
Corroded	36	36
Temperature Problem	33	33
Crack	31	31
Activation Failure	30	30
Noise, Audible	30	30
Fluid/Blood Leak	28	28
Flare or Flash	25	25
Material Integrity Problem	25	25
Intermittent Communication Failure	24	24
Activation Problem	24	24
Energy Output Problem	23	23
Mechanical Jam	21	21
Material Split, Cut or Torn	21	21
Fracture	20	20
Dent in Material	19	19
Device Alarm System	19	19
Failure to Clean Adequately	19	19
Application Program Problem	19	19
Component Missing	17	17
Use of Device Problem	17	17
Appropriate Term/Code Not Available	16	16
Moisture Damage	16	16

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8423	8424
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	14	14
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Electric Shock	3	3
Device Embedded In Tissue or Plaque	3	3
Superficial (First Degree) Burn	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