TPLC - Total Product Life Cycle

• Device: device, biopsy, endomyocardial
• Product Code: DWZ
• Regulation Number: 870.4075
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
FEHLING INSTRUMENTS GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2015	1	1
2016	1	1
2017	4	4
2018	7	7
2019	5	5
2020	5	5
2021	5	5
2022	14	14
2023	11	11

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	14	14
Difficult to Open or Close	7	7
Break	7	7
Physical Resistance/Sticking	5	5
Mechanical Problem	4	4
Difficult to Remove	3	3
Mechanical Jam	3	3
Mechanics Altered	2	2
Therapeutic or Diagnostic Output Failure	2	2
Fracture	2	2
Activation Failure	2	2
Failure to Obtain Sample	2	2
Detachment of Device or Device Component	2	2
Device Operates Differently Than Expected	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Contamination with Chemical or Other Material	1	1
Output Problem	1	1
Packaging Problem	1	1
Protective Measures Problem	1	1
Defective Device	1	1
Malposition of Device	1	1
Corroded	1	1
Sticking	1	1
Defective Component	1	1
Component Missing	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14	14
Insufficient Information	7	7
No Known Impact Or Consequence To Patient	7	7
Cardiac Tamponade	6	6
Cardiac Perforation	4	4
No Consequences Or Impact To Patient	4	4
Pericardial Effusion	3	3
Perforation of Vessels	3	3
Tachycardia	2	2
No Code Available	2	2
Ventricular Fibrillation	1	1
Vessel Or Plaque, Device Embedded In	1	1
Arrhythmia	1	1
Great Vessel Perforation	1	1
Discomfort	1	1
Embolism/Embolus	1	1
Thrombosis/Thrombus	1	1
Unspecified Tissue Injury	1	1
Foreign Body In Patient	1	1
No Information	1	1