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	20	21
Output Problem	16	16
Detachment of Device or Device Component	11	11
No Device Output	10	10
Insufficient Information	8	8
Overheating of Device	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Defective Device	5	5
Sparking	4	4
Electrical Power Problem	4	4
No Apparent Adverse Event	3	3
Activation Problem	3	3
Tear, Rip or Hole in Device Packaging	3	3
Therapeutic or Diagnostic Output Failure	3	3
Connection Problem	2	2
Failure to Power Up	2	2
Unintended Electrical Shock	2	2
Mechanical Problem	2	2
Separation Problem	2	2
Operating System Becomes Nonfunctional	2	2
Smoking	1	1
Defective Component	1	1
Material Puncture/Hole	1	1
Material Erosion	1	1
Misassembled During Installation	1	1
Suction Failure	1	1
Use of Device Problem	1	1
Material Deformation	1	1
Device Handling Problem	1	1
Image Display Error/Artifact	1	1
Communication or Transmission Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Increase in Pressure	1	1
Protective Measures Problem	1	1
Appropriate Term/Code Not Available	1	1
Suction Problem	1	1
Fire	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
Arcing of Electrodes	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	41	41
No Patient Involvement	21	21
No Consequences Or Impact To Patient	15	15
No Known Impact Or Consequence To Patient	4	4
Insufficient Information	4	5
Electric Shock	3	3
Perforation	3	3
Hepatitis	2	2
Bacterial Infection	2	2
Abdominal Pain	1	1
Hypovolemic Shock	1	1
Sepsis	1	1
No Information	1	1
Hematoma	1	1
Eye Burn	1	1
Fever	1	1
Foreign Body In Patient	1	1
Numbness	1	1
Hemorrhage/Bleeding	1	1