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
No Apparent Adverse Event	3	3
Tear, Rip or Hole in Device Packaging	3	3
Device Inoperable	3	3
Connection Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Operating System Becomes Nonfunctional	2	2
Separation Problem	2	2
Mechanical Problem	2	2
Loose or Intermittent Connection	2	2
Device Contamination with Chemical or Other Material	2	2
Unintended Electrical Shock	2	2
Failure to Power Up	2	2
Use of Device Problem	2	2
Device Operates Differently Than Expected	2	2
Material Fragmentation	1	1
Failure To Adhere Or Bond	1	1
Arcing of Electrodes	1	1
Device Displays Incorrect Message	1	1
Improper or Incorrect Procedure or Method	1	1
Electrical /Electronic Property Problem	1	1
Suction Problem	1	1
Protective Measures Problem	1	1
Increase in Pressure	1	1
Appropriate Term/Code Not Available	1	1
Material Deformation	1	1
Packaging Problem	1	1
Device Handling Problem	1	1
Charred	1	1
Gas/Air Leak	1	1
Material Discolored	1	1
Smoking	1	1
Defective Component	1	1
Crack	1	1
Image Display Error/Artifact	1	1
Suction Failure	1	1
Device Emits Odor	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
Hepatitis	2	2
Foreign Body In Patient	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
Hematoma	1	1
Perforation	1	1
Eye Burn	1	1
Burn, Thermal	1	1
Numbness	1	1
Hemorrhage/Bleeding	1	1
Internal Organ Perforation	1	1