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

Premarket Reviews
Manufacturer	Decision
OLYMPUS CORPORATION OF THE AMERICAS
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS WINTER & IBE GMBH
	SUBSTANTIALLY EQUIVALENT	1
SONOSCAPE MEDICAL CORP
	SUBSTANTIALLY EQUIVALENT	1
SONOSCAPE MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	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	513	513
Output Problem	452	452
Poor Quality Image	357	357
No Device Output	345	345
Display or Visual Feedback Problem	332	332
Break	289	289
No Visual Prompts/Feedback	272	272
Power Problem	198	198
Connection Problem	184	184
Defective Component	162	162
Optical Problem	141	141
Erratic or Intermittent Display	136	136
Image Display Error/Artifact	111	111
Key or Button Unresponsive/not Working	99	99
Mechanical Problem	87	87
Leak/Splash	68	68
Loose or Intermittent Connection	68	68
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	48	48
Electrical Power Problem	45	45
Physical Resistance/Sticking	38	38
Unexpected Shutdown	37	37
Temperature Problem	31	31
Adverse Event Without Identified Device or Use Problem	31	31
Noise, Audible	30	30
Corroded	30	30
Fluid/Blood Leak	28	28
Crack	26	26
Energy Output Problem	20	20
Flare or Flash	20	20
Mechanical Jam	19	19
Application Program Problem	19	19
Intermittent Communication Failure	18	18
Appropriate Term/Code Not Available	18	18
Contamination /Decontamination Problem	18	18
Material Integrity Problem	18	18
Component Missing	18	18
Use of Device Problem	17	17
Failure to Clean Adequately	16	16
Contamination	16	16
Device Alarm System	16	16
Microbial Contamination of Device	15	15
Device Reprocessing Problem	13	13
Moisture Damage	12	12

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	761	761
No Patient Involvement	297	297
No Known Impact Or Consequence To Patient	47	47
Foreign Body In Patient	21	21
Insufficient Information	10	10
Fever	10	10
Burn(s)	10	10
No Information	9	9
Injury	9	9
Perforation	9	9
Unspecified Infection	8	8
Electric Shock	8	8
Bowel Perforation	7	7
Device Embedded In Tissue or Plaque	6	6
Bacterial Infection	6	6
Urinary Tract Infection	5	5
Unspecified Tissue Injury	5	5
Dysuria	4	4
Hemorrhage/Bleeding	4	4
Patient Problem/Medical Problem	4	4
Aspiration/Inhalation	3	3
Chemical Exposure	3	3
Hematoma	3	3
No Code Available	3	3
Pain	3	3
Abdominal Pain	3	3
Abdominal Distention	2	2
Perforation of Esophagus	2	2
Adult Respiratory Distress Syndrome	2	2
Vomiting	2	2
Pneumonia	2	2
Death	2	2
Cough	2	2
Partial thickness (Second Degree) Burn	2	2
Superficial (First Degree) Burn	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Airway Obstruction	2	2
Inflammation	1	1
Burn, Thermal	1	1
Bowel Burn	1	1
Blister	1	1
Rupture	1	1
Sepsis	1	1
Diarrhea	1	1
Cramp(s)	1	1
Septic Shock	1	1
Exposure to Body Fluids	1	1
Chest Pain	1	1
Discomfort	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
7	Olympus Corporation of the Americas	II	Feb-24-2017