TPLC - Total Product Life Cycle

show TPLC since

Device	ultrasound bronchoscope
Definition	An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code	PSV
Regulation Number	892.1550
Device Class	2

Premarket Reviews
Manufacturer	Decision
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	527	527
Detachment of Device or Device Component	152	152
Break	138	138
Failure to Clean Adequately	127	127
Communication or Transmission Problem	125	125
Microbial Contamination of Device	110	110
Device Reprocessing Problem	110	110
Peeled/Delaminated	84	84
Poor Quality Image	67	67
Material Rupture	54	54
Adverse Event Without Identified Device or Use Problem	48	48
Leak/Splash	39	39
Material Split, Cut or Torn	34	34
Material Puncture/Hole	33	33
Fluid/Blood Leak	30	30
Material Separation	28	28
Separation Problem	22	22
Contamination	20	20
Device Dislodged or Dislocated	19	19
Loose or Intermittent Connection	17	17
Component Missing	15	15
Mechanical Problem	15	15
Display or Visual Feedback Problem	12	12
Use of Device Problem	11	11
Contamination /Decontamination Problem	11	11
Scratched Material	10	10
Device Fell	9	9
Image Display Error/Artifact	9	9
Device Slipped	9	9
Material Deformation	8	8
Physical Resistance/Sticking	8	8
Defective Device	8	8
Device Damaged by Another Device	8	8
Erratic or Intermittent Display	7	7
Deflation Problem	7	7
Material Discolored	7	7
Crack	5	5
Device Contamination with Chemical or Other Material	4	4
Unintended Movement	4	4
Material Fragmentation	4	4
Fitting Problem	4	4
Defective Component	3	3
Output Problem	3	3
Corroded	3	3
Improper or Incorrect Procedure or Method	3	3
Material Twisted/Bent	3	3
Dent in Material	3	3
Material Too Rigid or Stiff	3	3
Image Orientation Incorrect	2	2
Partial Blockage	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1486	1486
No Consequences Or Impact To Patient	86	86
No Patient Involvement	65	65
Foreign Body In Patient	37	37
Fungal Infection	27	27
Bacterial Infection	27	27
No Known Impact Or Consequence To Patient	23	23
Hemorrhage/Bleeding	16	16
Unspecified Infection	13	13
Pneumonia	13	13
Pneumothorax	11	11
Insufficient Information	10	10
Respiratory Tract Infection	9	9
Hypoxia	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Respiratory Failure	6	6
Airway Obstruction	6	6
Fever	6	6
Hemoptysis	5	5
Cardiac Arrest	5	5
Dyspnea	5	5
Sleep Dysfunction	3	3
Low Blood Pressure/ Hypotension	3	3
Device Embedded In Tissue or Plaque	2	2
Decreased Respiratory Rate	2	2
Respiratory Insufficiency	2	2
Fibrosis	2	2
Unspecified Tissue Injury	2	2
Bronchospasm	2	2
Perforation of Vessels	2	2
Cough	2	2
Abscess	2	2
Chest Pain	2	2
Pulmonary Emphysema	2	2
Hematoma	2	2
Sepsis	2	2
Air Embolism	2	2
Patient Problem/Medical Problem	2	2
Vomiting	1	1
Septic Shock	1	1
Unspecified Eye / Vision Problem	1	1
Laceration(s)	1	1
Oversedation	1	1
Confusion/ Disorientation	1	1
Asthma	1	1
Swelling/ Edema	1	1
Shaking/Tremors	1	1
Pleural Empyema	1	1
No Information	1	1
Unspecified Respiratory Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aizu Olympus Co., Ltd.	II	Nov-17-2023
2	Olympus Corporation of the Americas	II	Aug-31-2023