TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
GUANGZHOU POTENT MEDICAL EQUIPMENT JOINT-STOCK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
NORTHGATE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
WALZ ELEKTRONIK GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	12	13
Detachment of Device or Device Component	11	11
Output Problem	7	7
Insufficient Information	7	7
Overheating of Device	6	6
Sparking	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Electrical Power Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Tear, Rip or Hole in Device Packaging	3	3
No Apparent Adverse Event	3	3
Separation Problem	2	2
Failure to Power Up	2	2
Connection Problem	2	2
Fire	1	1
Image Display Error/Artifact	1	1
Unintended Electrical Shock	1	1
Material Erosion	1	1
Smoking	1	1
Use of Device Problem	1	1
Device Handling Problem	1	1
Protective Measures Problem	1	1
Firing Problem	1	1
Electrical /Electronic Property Problem	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	1
No Device Output	1	1
Arcing of Electrodes	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	41	41
Insufficient Information	4	5
Perforation	3	3
Electric Shock	2	2
Hepatitis	2	2
No Patient Involvement	2	2
Bacterial Infection	2	2
Hypovolemic Shock	1	1
Sepsis	1	1
Hematoma	1	1
Eye Burn	1	1
Fever	1	1
Foreign Body In Patient	1	1
Hemorrhage/Bleeding	1	1