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	859	859
Detachment of Device or Device Component	392	392
Failure to Clean Adequately	257	257
Communication or Transmission Problem	237	237
Break	223	223
Poor Quality Image	186	186
Device Reprocessing Problem	176	176
Peeled/Delaminated	133	133
Microbial Contamination of Device	126	126
Material Puncture/Hole	80	80
Adverse Event Without Identified Device or Use Problem	62	62
Material Split, Cut or Torn	57	57
Material Rupture	55	55
Leak/Splash	49	49
Material Separation	46	46
Display or Visual Feedback Problem	34	34
Fluid/Blood Leak	34	34
Material Deformation	32	32
Contamination	32	32
Loose or Intermittent Connection	30	30
Image Display Error/Artifact	29	29
Corroded	27	27
Component Missing	24	24
Gas/Air Leak	23	23
Scratched Material	23	23
Separation Problem	21	21
Degraded	21	21
Contamination /Decontamination Problem	19	19
Device Dislodged or Dislocated	18	18
Mechanical Problem	17	17
Erratic or Intermittent Display	17	17
Crack	15	15
Physical Resistance/Sticking	14	14
Optical Problem	13	13
Device Damaged by Another Device	12	12
Device Slipped	11	11
Loss of or Failure to Bond	11	11
Use of Device Problem	11	11
Connection Problem	10	10
Device Fell	9	9
Defective Device	9	9
Obstruction of Flow	9	9
Fracture	8	8
Material Discolored	8	8
Material Fragmentation	8	8
Output Problem	7	7
Mechanical Jam	7	7
Deflation Problem	7	7
Device Contamination with Chemical or Other Material	6	6
Residue After Decontamination	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2777	2777
No Consequences Or Impact To Patient	80	80
No Patient Involvement	65	65
Foreign Body In Patient	41	41
Insufficient Information	29	29
Bacterial Infection	28	28
Fungal Infection	25	25
Hemorrhage/Bleeding	18	18
Unspecified Infection	13	13
Subclinical 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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
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
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
Patient Problem/Medical Problem	2	2
Air Embolism	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
Pleural Empyema	1	1
No Information	1	1
Shaking/Tremors	1	1
Swelling/ Edema	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