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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	20	20
Output Problem	14	14
No Device Output	10	10
Detachment of Device or Device Component	10	10
Insufficient Information	8	8
Overheating of Device	6	6
Defective Device	5	5
Sparking	4	4
Electrical Power Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Activation Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
No Apparent Adverse Event	3	3
Tear, Rip or Hole in Device Packaging	3	3
Operating System Becomes Nonfunctional	2	2
Separation Problem	2	2
Mechanical Problem	2	2
Unintended Electrical Shock	2	2
Connection Problem	2	2
Failure to Power Up	2	2
Arcing of Electrodes	1	1
Improper or Incorrect Procedure or Method	1	1
Loose or Intermittent Connection	1	1
Electrical /Electronic Property Problem	1	1
Suction Problem	1	1
Appropriate Term/Code Not Available	1	1
Protective Measures Problem	1	1
Increase in Pressure	1	1
Device Contamination with Chemical or Other Material	1	1
Device Handling Problem	1	1
Material Deformation	1	1
Use of Device Problem	1	1
Misassembled During Installation	1	1
Defective Component	1	1
Smoking	1	1
Material Puncture/Hole	1	1
Material Erosion	1	1
Suction Failure	1	1
Image Display Error/Artifact	1	1
Communication or Transmission Problem	1	1
Fire	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	37	37
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	4
Electric Shock	3	3
Perforation	2	2
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