TPLC - Total Product Life Cycle

• Device: bronchoscope accessory
• Definition: 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: KTI
• Regulation Number: 874.4680
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
DISA MEDINOTEC
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN TT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GA HEALTH COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
M/S MERIL LIFE SCIENCES PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	2
PRAXIS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SERPEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	14	14
2019	27	27
2020	37	37
2021	47	47
2022	131	131
2023	114	114

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	67	67
Mechanical Problem	52	52
Detachment of Device or Device Component	38	38
Burst Container or Vessel	28	28
Material Puncture/Hole	24	24
Retraction Problem	24	24
Leak/Splash	22	22
Material Separation	21	21
Material Twisted/Bent	20	20
Physical Resistance/Sticking	18	18
Use of Device Problem	16	16
Adverse Event Without Identified Device or Use Problem	13	13
Device Fell	12	12
Defective Device	8	8
Material Split, Cut or Torn	7	7
Difficult to Advance	7	7
Unintended Movement	6	6
Difficult to Remove	6	6
Output Problem	5	5
Separation Failure	5	5
Mechanical Jam	4	4
Separation Problem	4	4
Failure to Obtain Sample	4	4
Device Slipped	4	4
Material Fragmentation	4	4
Inflation Problem	3	3
Defective Component	3	3
Component Missing	3	3
Failure to Advance	3	3
Deformation Due to Compressive Stress	3	3
Device Dislodged or Dislocated	3	3
Material Deformation	2	2
Insufficient Information	2	2
Unstable	2	2
Improper or Incorrect Procedure or Method	2	2
Entrapment of Device	2	2
Fluid/Blood Leak	1	1
Fracture	1	1
Hole In Material	1	1
Bent	1	1
Loose or Intermittent Connection	1	1
Device Reprocessing Problem	1	1
Collapse	1	1
Deflation Problem	1	1
Difficult or Delayed Positioning	1	1
Failure to Discharge	1	1
Disconnection	1	1
Display or Visual Feedback Problem	1	1
Fitting Problem	1	1
Material Perforation	1	1
Material Too Rigid or Stiff	1	1
Activation, Positioning or Separation Problem	1	1
Failure to Disconnect	1	1
Device Handling Problem	1	1
Activation Failure	1	1
Positioning Problem	1	1
Scratched Material	1	1
Torn Material	1	1
Inadequate User Interface	1	1
Compatibility Problem	1	1
Difficult to Open or Close	1	1
Fail-Safe Did Not Operate	1	1
Failure to Eject	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	248	248
No Consequences Or Impact To Patient	48	48
Foreign Body In Patient	27	27
No Known Impact Or Consequence To Patient	22	22
Insufficient Information	10	10
Hemorrhage/Bleeding	4	4
Hypoxia	3	3
No Code Available	3	3
Device Embedded In Tissue or Plaque	2	2
Chest Pain	2	2
Fever	1	1
Hemoptysis	1	1
Low Blood Pressure/ Hypotension	1	1
Unspecified Infection	1	1
Pneumonia	1	1
Scar Tissue	1	1
Perforation of Vessels	1	1
Tooth Fracture	1	1
Needle Stick/Puncture	1	1
Low Oxygen Saturation	1	1
Respiratory Failure	1	1
Decreased Respiratory Rate	1	1
Sleep Dysfunction	1	1
No Patient Involvement	1	1
Abscess	1	1
Cough	1	1
Unspecified Respiratory Problem	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bryan Medical Inc	II	Jul-17-2023
2	Richard Wolf GmbH	II	Feb-06-2019