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	3242	3245
No Display/Image	1281	1284
Electrical /Electronic Property Problem	1144	1145
Poor Quality Image	892	894
Output Problem	849	849
Failure to Power Up	627	627
No Device Output	583	583
Break	463	463
Display or Visual Feedback Problem	423	423
No Visual Prompts/Feedback	396	396
Connection Problem	275	278
Power Problem	257	257
Erratic or Intermittent Display	231	232
Activation Failure	204	204
Optical Problem	195	195
Defective Component	183	183
Key or Button Unresponsive/not Working	146	146
Leak/Splash	146	146
Image Display Error/Artifact	138	138
Loose or Intermittent Connection	117	117
Mechanical Problem	110	111
Failure to Clean Adequately	86	86
Overheating of Device	78	78
Activation Problem	77	77
Intermittent Loss of Power	72	72
Loss of Power	69	69
Detachment of Device or Device Component	63	63
Defective Device	63	63
Physical Resistance/Sticking	62	62
Corroded	57	57
Electrical Power Problem	56	56
Crack	53	53
Dent in Material	49	49
Unexpected Shutdown	49	49
Material Integrity Problem	42	42
Temperature Problem	39	39
Material Split, Cut or Torn	39	39
Noise, Audible	36	36
Intermittent Communication Failure	35	35
Degraded	34	34
Mechanical Jam	33	33
Environmental Particulates	33	33
Moisture Damage	32	32
Contamination	32	32
Fluid/Blood Leak	32	32
Fracture	30	30
Flare or Flash	28	28
Energy Output Problem	25	25
Use of Device Problem	24	24
Material Deformation	22	22

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11231	11241
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	25	30
Insufficient Information	22	25
Perforation	9	9
Burn(s)	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Cough	5	5
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
Airway Obstruction	3	3
Electric Shock	3	3
Aspiration/Inhalation	2	2
Injury	2	2
Perforation of Esophagus	2	2
No Information	2	2
Discomfort	2	2
Adult Respiratory Distress Syndrome	2	2
Pain	2	2
Laceration(s)	2	2
Partial thickness (Second Degree) Burn	2	2
Hemorrhage/Bleeding	2	2
Unspecified Infection	2	2
Superficial (First Degree) Burn	2	2
Burn, Thermal	1	1
Bowel Burn	1	1
Blister	1	1
Rupture	1	1
Abdominal Distention	1	1
Bowel Perforation	1	1
Unspecified Hepatic or Biliary Problem	1	1
Asystole	1	1
Sepsis	1	1
Arrhythmia	1	1
Unspecified Respiratory Problem	1	1
Full thickness (Third Degree) Burn	1	1
Low Oxygen Saturation	1	1
Abdominal Pain	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