TPLC - Total Product Life Cycle

show TPLC since

Device	lithotriptor, electro-hydraulic
Product Code	FFK
Regulation Number	876.4480
Device Class	2

Premarket Reviews
Manufacturer	Decision
CYBERSONICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
ELMED USA
	SUBSTANTIALLY EQUIVALENT	1
EMS ELECTRO MEDICAL SYSTEMS SA
	SUBSTANTIALLY EQUIVALENT	2
MED-SONICS CORP
	SUBSTANTIALLY EQUIVALENT	2
MED-SONICS CORP.
	SUBSTANTIALLY EQUIVALENT	1
NORTHGATE TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	2
WALZ ELEKTRONIK GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	51	51
Output Problem	14	14
No Device Output	11	11
Detachment of Device or Device Component	11	11
Overheating of Device	9	9
Insufficient Information	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Defective Device	5	5
Device Packaging Compromised	5	5
Sparking	4	4
Electrical Power Problem	4	4
Metal Shedding Debris	4	4
Activation Problem	3	3
Detachment Of Device Component	3	3
Device Inoperable	3	3
Therapeutic or Diagnostic Output Failure	3	3
Connection Problem	3	3
Tear, Rip or Hole in Device Packaging	3	3
No Apparent Adverse Event	3	3
Operating System Becomes Nonfunctional	2	2
Separation Problem	2	2
Mechanical Problem	2	2
Unintended Electrical Shock	2	2
Loose or Intermittent Connection	2	2
Device Operates Differently Than Expected	2	2
Use of Device Problem	2	2
Failure to Power Up	2	2
Device Contamination with Chemical or Other Material	2	2
Arcing of Electrodes	1	1
Improper or Incorrect Procedure or Method	1	1
Electrical /Electronic Property Problem	1	1
Device Displays Incorrect Message	1	1
Suction Problem	1	1
Protective Measures Problem	1	1
Appropriate Term/Code Not Available	1	1
Increase in Pressure	1	1
Device Emits Odor	1	1
Device Disinfection Or Sterilization Issue	1	1
Device Handling Problem	1	1
Material Deformation	1	1
Packaging Problem	1	1
Gas/Air Leak	1	1
Charred	1	1
Material Discolored	1	1
Material Fragmentation	1	1
Failure To Adhere Or Bond	1	1
Misassembled During Installation	1	1
Difficult to Remove	1	1
Smoking	1	1
Defective Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	39	39
No Clinical Signs, Symptoms or Conditions	37	37
No Known Impact Or Consequence To Patient	24	24
No Patient Involvement	23	23
No Code Available	5	5
No Information	4	4
Insufficient Information	4	4
Electric Shock	3	3
Burn(s)	3	3
Foreign Body In Patient	2	2
Hepatitis	2	2
Bacterial Infection	2	2
Device Embedded In Tissue or Plaque	2	2
Abdominal Pain	1	1
Hypovolemic Shock	1	1
Death	1	1
Sepsis	1	1
Perforation	1	1
Hematoma	1	1
Burn, Thermal	1	1
Eye Burn	1	1
Numbness	1	1
Hemorrhage/Bleeding	1	1
Internal Organ Perforation	1	1