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	2806	2806
Electrical /Electronic Property Problem	1112	1112
No Display/Image	1017	1017
Poor Quality Image	659	659
Output Problem	633	633
Failure to Power Up	576	576
No Device Output	496	496
Display or Visual Feedback Problem	384	384
No Visual Prompts/Feedback	368	368
Break	367	367
Connection Problem	223	223
Power Problem	220	220
Erratic or Intermittent Display	181	181
Defective Component	173	173
Optical Problem	169	169
Image Display Error/Artifact	125	125
Key or Button Unresponsive/not Working	118	118
Leak/Splash	111	111
Mechanical Problem	101	101
Loose or Intermittent Connection	98	98
Activation Failure	68	68
Loss of Power	67	67
Intermittent Loss of Power	67	67
Overheating of Device	66	66
Defective Device	60	60
Detachment of Device or Device Component	55	55
Electrical Power Problem	50	50
Physical Resistance/Sticking	47	47
Unexpected Shutdown	42	42
Corroded	40	40
Crack	35	35
Temperature Problem	34	34
Noise, Audible	33	33
Activation Problem	33	33
Material Integrity Problem	31	31
Fluid/Blood Leak	28	28
Intermittent Communication Failure	28	28
Material Split, Cut or Torn	27	27
Failure to Clean Adequately	27	27
Dent in Material	25	25
Flare or Flash	25	25
Energy Output Problem	24	24
Mechanical Jam	23	23
Device Alarm System	20	20
Fracture	20	20
Application Program Problem	19	19
Moisture Damage	19	19
Component Missing	18	18
Use of Device Problem	18	18
Appropriate Term/Code Not Available	16	16

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9251	9251
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	24	24
Insufficient Information	18	18
Perforation	9	9
Burn(s)	9	9
Unspecified Tissue Injury	5	5
Patient Problem/Medical Problem	4	4
Dysuria	4	4
Fever	4	4
Cough	4	4
Urinary Tract Infection	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Electric Shock	3	3
Airway Obstruction	3	3
Device Embedded In Tissue or Plaque	3	3
Superficial (First Degree) Burn	2	2
Adult Respiratory Distress Syndrome	2	2
No Information	2	2
Perforation of Esophagus	2	2
Aspiration/Inhalation	2	2
Injury	2	2
Partial thickness (Second Degree) Burn	2	2
Hemorrhage/Bleeding	2	2
Abdominal Pain	1	1
Arrhythmia	1	1
Sepsis	1	1
Bowel Perforation	1	1
Abdominal Distention	1	1
Burn, Thermal	1	1
Bowel Burn	1	1
Blister	1	1
Rupture	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	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