TPLC - Total Product Life Cycle

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Device	ultrasound bronchoscope
Regulation Description	Ultrasonic pulsed doppler imaging system.
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	733	733
Detachment of Device or Device Component	231	231
Communication or Transmission Problem	209	209
Break	184	184
Failure to Clean Adequately	180	180
Device Reprocessing Problem	138	138
Microbial Contamination of Device	120	120
Peeled/Delaminated	102	102
Poor Quality Image	101	101
Material Puncture/Hole	73	73
Material Rupture	55	55
Leak/Splash	46	46
Adverse Event Without Identified Device or Use Problem	46	46
Material Split, Cut or Torn	45	45
Fluid/Blood Leak	34	34
Material Separation	34	34
Loose or Intermittent Connection	26	26
Contamination	25	25
Separation Problem	21	21
Display or Visual Feedback Problem	20	20
Device Dislodged or Dislocated	18	18
Component Missing	17	17
Material Deformation	16	16
Image Display Error/Artifact	16	16
Scratched Material	16	16
Mechanical Problem	15	15
Contamination /Decontamination Problem	15	15
Physical Resistance/Sticking	13	13
Device Damaged by Another Device	12	12
Device Slipped	11	11
Use of Device Problem	11	11
Erratic or Intermittent Display	10	10
Device Fell	9	9
Defective Device	8	8
Material Fragmentation	8	8
Material Discolored	8	8
Deflation Problem	7	7
Degraded	7	7
Corroded	7	7
Optical Problem	6	6
Crack	6	6
Connection Problem	6	6
Gas/Air Leak	6	6
Device Contamination with Chemical or Other Material	5	5
Unintended Movement	4	4
Defective Component	4	4
Mechanical Jam	4	4
Fitting Problem	4	4
Material Too Rigid or Stiff	4	4
Output Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2145	2145
No Consequences Or Impact To Patient	80	80
No Patient Involvement	65	65
Foreign Body In Patient	41	41
Bacterial Infection	28	28
Fungal Infection	25	25
Insufficient Information	19	19
Hemorrhage/Bleeding	16	16
Unspecified Infection	13	13
Pneumonia	13	13
No Known Impact Or Consequence To Patient	12	12
Pneumothorax	11	11
Hypoxia	9	9
Respiratory Tract Infection	9	9
Respiratory Failure	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Airway Obstruction	6	6
Fever	6	6
Hemoptysis	5	5
Cardiac Arrest	5	5
Dyspnea	5	5
Low Blood Pressure/ Hypotension	3	3
Sleep Dysfunction	3	3
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
Septic Shock	1	1
Vomiting	1	1
Unspecified Eye / Vision Problem	1	1
Oversedation	1	1
Laceration(s)	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
Bronchial Hemorrhage	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