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
Detachment of Device or Device Component	11	11
No Device Output	11	11
Overheating of Device	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Insufficient Information	8	8
Device Packaging Compromised	5	5
Defective Device	5	5
Metal Shedding Debris	4	4
Sparking	4	4
Electrical Power Problem	4	4
No Apparent Adverse Event	3	3
Tear, Rip or Hole in Device Packaging	3	3
Connection Problem	3	3
Activation Problem	3	3
Device Inoperable	3	3
Detachment Of Device Component	3	3
Therapeutic or Diagnostic Output Failure	3	3
Device Operates Differently Than Expected	2	2
Failure to Power Up	2	2
Use of Device Problem	2	2
Mechanical Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Loose or Intermittent Connection	2	2
Operating System Becomes Nonfunctional	2	2
Separation Problem	2	2
Unintended Electrical Shock	2	2
Protective Measures Problem	1	1
Increase in Pressure	1	1
Appropriate Term/Code Not Available	1	1
Fire	1	1
Communication or Transmission Problem	1	1
Arcing of Electrodes	1	1
Device Handling Problem	1	1
Packaging Problem	1	1
Material Deformation	1	1
Smoking	1	1
Defective Component	1	1
Material Puncture/Hole	1	1
Material Erosion	1	1
Image Display Error/Artifact	1	1
Suction Failure	1	1
Crack	1	1
Activation, Positioning or Separation Problem	1	1
Leak/Splash	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

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