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