TPLC - Total Product Life Cycle

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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

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	614	614
Detachment of Device or Device Component	160	160
Communication or Transmission Problem	154	154
Failure to Clean Adequately	146	146
Break	140	140
Device Reprocessing Problem	120	120
Microbial Contamination of Device	110	110
Peeled/Delaminated	87	87
Poor Quality Image	79	79
Material Rupture	55	55
Material Puncture/Hole	48	48
Adverse Event Without Identified Device or Use Problem	45	45
Leak/Splash	42	42
Material Split, Cut or Torn	36	36
Material Separation	31	31
Fluid/Blood Leak	30	30
Separation Problem	21	21
Contamination	20	20
Loose or Intermittent Connection	18	18
Device Dislodged or Dislocated	18	18
Component Missing	16	16
Mechanical Problem	15	15
Display or Visual Feedback Problem	14	14
Contamination /Decontamination Problem	13	13
Device Damaged by Another Device	12	12
Image Display Error/Artifact	12	12
Use of Device Problem	11	11
Scratched Material	10	10
Device Slipped	9	9
Device Fell	9	9
Physical Resistance/Sticking	8	8
Material Deformation	8	8
Material Fragmentation	8	8
Defective Device	8	8
Material Discolored	7	7
Erratic or Intermittent Display	7	7
Deflation Problem	7	7
Device Contamination with Chemical or Other Material	5	5
Crack	5	5
Fitting Problem	4	4
Unintended Movement	4	4
Material Too Rigid or Stiff	4	4
Mechanical Jam	3	3
Improper or Incorrect Procedure or Method	3	3
Defective Component	3	3
Degraded	3	3
Connection Problem	3	3
Dent in Material	3	3
Corroded	3	3
Output Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1690	1690
No Consequences Or Impact To Patient	80	80
No Patient Involvement	65	65
Foreign Body In Patient	41	41
Fungal Infection	25	25
Bacterial Infection	25	25
Hemorrhage/Bleeding	16	16
Pneumonia	13	13
Unspecified Infection	12	12
No Known Impact Or Consequence To Patient	12	12
Pneumothorax	11	11
Insufficient Information	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
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
Wheezing	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