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	930	930
Detachment of Device or Device Component	508	508
Failure to Clean Adequately	302	302
Communication or Transmission Problem	263	263
Poor Quality Image	226	226
Break	202	202
Device Reprocessing Problem	190	190
Peeled/Delaminated	153	153
Microbial Contamination of Device	124	124
Material Puncture/Hole	78	78
Adverse Event Without Identified Device or Use Problem	60	61
Material Split, Cut or Torn	54	54
Material Rupture	52	52
Material Separation	45	45
Corroded	42	42
Display or Visual Feedback Problem	37	37
Contamination	37	37
Material Deformation	35	35
Loose or Intermittent Connection	33	33
Gas/Air Leak	29	29
Degraded	29	29
Image Display Error/Artifact	29	29
Erratic or Intermittent Display	27	27
Leak/Splash	24	24
Component Missing	24	24
Separation Problem	21	21
Contamination /Decontamination Problem	20	20
Device Dislodged or Dislocated	17	17
Mechanical Problem	17	17
Physical Resistance/Sticking	15	15
Scratched Material	15	15
Loss of or Failure to Bond	14	14
Device Damaged by Another Device	14	14
Crack	13	13
Optical Problem	13	13
Fluid/Blood Leak	12	12
Connection Problem	11	11
Device Slipped	11	11
Residue After Decontamination	10	10
Mechanical Jam	9	9
Fracture	8	8
Unstable	8	8
Material Fragmentation	8	8
Obstruction of Flow	8	8
Device Fell	7	7
Deflation Problem	7	7
Dent in Material	7	7
Output Problem	6	6
Device Contamination with Chemical or Other Material	6	6
Moisture or Humidity Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3139	3139
Foreign Body In Patient	40	40
Insufficient Information	32	32
Bacterial Infection	28	28
Fungal Infection	25	25
Hemorrhage/Bleeding	18	18
Subclinical Infection	13	13
Pneumonia	13	13
Unspecified Infection	12	12
Pneumothorax	11	12
No Consequences Or Impact To Patient	10	10
Hypoxia	9	9
Respiratory Tract Infection	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Respiratory Failure	6	6
Airway Obstruction	6	6
Fever	6	6
Cardiac Arrest	5	5
No Patient Involvement	5	5
Dyspnea	5	5
Hemoptysis	4	4
Sleep Dysfunction	3	3
Low Blood Pressure/ Hypotension	3	3
Decreased Respiratory Rate	2	2
Respiratory Insufficiency	2	2
Fibrosis	2	2
Unspecified Tissue Injury	2	2
Cough	2	2
Bronchospasm	2	2
Perforation of Vessels	2	2
Abscess	2	2
Chest Pain	2	2
Hematoma	2	2
Pulmonary Emphysema	2	2
Gastrointestinal Hemorrhage	2	2
Sepsis	2	2
Air Embolism	2	2
Vomiting	1	1
Unspecified Eye / Vision Problem	1	1
Septic Shock	1	1
Laceration(s)	1	1
Oversedation	1	1
Confusion/ Disorientation	1	1
Asthma	1	1
Pleural Empyema	1	1
Shaking/Tremors	1	1
Swelling/ Edema	1	1
Unspecified Respiratory Problem	1	1
Wheezing	1	1
Bronchial Hemorrhage	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