TPLC - Total Product Life Cycle

show TPLC since

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	2216	2217
Electrical /Electronic Property Problem	1086	1086
No Display/Image	677	677
Failure to Power Up	512	512
Output Problem	451	451
Poor Quality Image	357	357
No Device Output	345	345
Display or Visual Feedback Problem	331	331
Break	282	282
No Visual Prompts/Feedback	272	272
Power Problem	198	198
Connection Problem	184	184
Defective Component	162	162
Optical Problem	140	140
Erratic or Intermittent Display	136	136
Image Display Error/Artifact	110	110
Key or Button Unresponsive/not Working	99	99
Mechanical Problem	87	87
Loose or Intermittent Connection	68	68
Leak/Splash	67	67
Loss of Power	60	60
Overheating of Device	58	58
Defective Device	54	54
Intermittent Loss of Power	52	52
Detachment of Device or Device Component	47	47
Electrical Power Problem	45	45
Physical Resistance/Sticking	38	38
Unexpected Shutdown	37	37
Temperature Problem	31	31
Corroded	30	30
Noise, Audible	29	29
Fluid/Blood Leak	28	28
Crack	26	26
Flare or Flash	20	20
Energy Output Problem	20	20
Application Program Problem	19	19
Mechanical Jam	19	19
Component Missing	18	18
Material Integrity Problem	18	18
Intermittent Communication Failure	18	18
Use of Device Problem	17	17
Device Alarm System	16	16
Failure to Clean Adequately	16	16
Appropriate Term/Code Not Available	15	15
Adverse Event Without Identified Device or Use Problem	14	14
Moisture Damage	12	12
Contamination	12	12
Smoking	11	11
Output below Specifications	11	11
Circuit Failure	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6982	6983
No Consequences Or Impact To Patient	738	738
No Patient Involvement	296	296
No Known Impact Or Consequence To Patient	33	33
Foreign Body In Patient	20	20
Insufficient Information	10	10
Burn(s)	9	9
Perforation	7	7
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
6	Olympus Corporation of the Americas	II	Mar-12-2019