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	1186	1186
Detachment of Device or Device Component	1086	1086
Failure to Clean Adequately	443	443
Communication or Transmission Problem	373	373
Poor Quality Image	358	358
Device Reprocessing Problem	269	269
Break	256	256
Peeled/Delaminated	213	213
Material Fragmentation	177	177
Corroded	168	168
Microbial Contamination of Device	125	125
Material Split, Cut or Torn	102	102
Material Separation	90	90
Contamination	85	85
Material Puncture/Hole	84	84
Erratic or Intermittent Display	78	78
Adverse Event Without Identified Device or Use Problem	77	78
Display or Visual Feedback Problem	68	68
Loss of or Failure to Bond	64	64
Material Rupture	54	54
Material Deformation	51	51
Degraded	51	51
Image Display Error/Artifact	49	49
Loose or Intermittent Connection	43	43
Gas/Air Leak	38	38
Crack	36	36
Residue After Decontamination	30	30
Contamination /Decontamination Problem	28	28
Component Missing	28	28
Scratched Material	25	25
Fracture	24	24
Leak/Splash	24	24
Fluid/Blood Leak	22	22
Separation Problem	22	22
Connection Problem	21	21
Optical Problem	19	19
Mechanical Problem	18	18
Physical Resistance/Sticking	17	17
Unstable	17	17
Obstruction of Flow	15	15
Device Damaged by Another Device	12	12
Device Slipped	12	12
Dent in Material	11	11
Mechanical Jam	9	9
Material Integrity Problem	9	9
Signal Artifact/Noise	9	9
Positioning Failure	9	9
Moisture or Humidity Problem	7	7
Partial Blockage	7	7
Device Contamination with Chemical or Other Material	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4918	4918
Foreign Body In Patient	41	41
Insufficient Information	40	40
Unspecified Infection	32	32
Bacterial Infection	28	28
Fungal Infection	25	25
Hemorrhage/Blood Loss/Bleeding	18	18
Pneumonia	13	13
Subclinical Infection	13	13
Pneumothorax	12	13
No Consequences Or Impact To Patient	10	10
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	10	10
Hypoxia	9	9
Respiratory Tract Infection	9	9
Airway Obstruction	6	6
Fever	6	6
Respiratory Failure	6	6
No Patient Involvement	5	5
Cardiac Arrest	5	5
Dyspnea	5	5
Hemoptysis	4	4
Low Blood Pressure/ Hypotension	3	3
Sleep Dysfunction	3	3
Abscess	2	2
Pulmonary Emphysema	2	2
Respiratory Insufficiency	2	2
Fibrosis	2	2
Chest Pain	2	2
Gastrointestinal Hemorrhage	2	2
Hematoma	2	2
Cough	2	2
Air Embolism	2	2
Upper Respiratory Tract Injury	2	2
Bronchospasm	2	2
Sepsis	2	2
Unspecified Tissue Injury	2	2
Perforation of Vessels	2	2
Decreased Respiratory Rate	2	2
Swelling/ Edema	1	1
Septic Shock	1	1
High Blood Pressure/ Hypertension	1	1
Laceration(s)	1	1
Low Oxygen Saturation	1	1
Arrhythmia	1	1
Asthma	1	1
Unspecified Respiratory Problem	1	1
Weight Changes	1	1
Wheezing	1	1
Oversedation	1	1
Sore Throat	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