TPLC - Total Product Life Cycle

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Device	instrument, surgical, orthopedic, pneumatic powered & accessory/attachment
Product Code	HSZ
Regulation Number	878.4820
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	86	86
Failure to Cut	25	25
Air Leak	22	22
Material Rupture	21	21
Entrapment of Device	17	17
Leak/Splash	13	13
Device Operates Differently Than Expected	9	9
Overheating of Device	8	8
Burst Container or Vessel	7	7
Noise, Audible	5	5
Device Inoperable	5	5
Device-Device Incompatibility	5	5
Fracture	4	4
Detachment Of Device Component	3	3
Excessive Heating	3	3
Output below Specifications	2	2
Mechanical Jam	2	2
Partial Blockage	2	2
Material Deformation	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Use of Device Problem	2	2
Vibration	2	2
Failure to Align	1	1
Improper Flow or Infusion	1	1
Expulsion	1	1
Component Missing	1	1
Contamination /Decontamination Problem	1	1
Material Integrity Problem	1	1
Sticking	1	1
No Apparent Adverse Event	1	1
Defective Component	1	1
Fitting Problem	1	1
Maintenance Does Not Comply To Manufacturers Recommendations	1	1
Power Problem	1	1
Intermittent Continuity	1	1
Connection Problem	1	1
Naturally Worn	1	1
Disassembly	1	1
Insufficient Information	1	1
Device Displays Incorrect Message	1	1
Unintended Movement	1	1
Crack	1	1
Component Falling	1	1
Fluid/Blood Leak	1	1
Hole In Material	1	1
Dull, Blunt	1	1
Physical Resistance/Sticking	1	1
Temperature Problem	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	87	87
No Known Impact Or Consequence To Patient	54	54
No Consequences Or Impact To Patient	28	28
Foreign Body In Patient	18	18
No Patient Involvement	18	18
No Code Available	6	6
Insufficient Information	6	6
No Information	5	5
Device Embedded In Tissue or Plaque	3	3
Burn(s)	2	2
Hearing Impairment	1	1
Unspecified Infection	1	1
Superficial (First Degree) Burn	1	1
Foreign Body Reaction	1	1
Laceration(s)	1	1
Pain	1	1
Tinnitus	1	1