TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	555	555
Vibration	223	223
Material Separation	79	79
Material Fragmentation	62	62
Physical Resistance/Sticking	56	56
Mechanical Jam	34	34
Overheating of Device	18	18
Connection Problem	15	15
Mechanical Problem	10	10
Device Markings/Labelling Problem	9	9
Noise, Audible	9	9
Use of Device Problem	7	7
Contamination /Decontamination Problem	6	6
Material Twisted/Bent	6	6
Output Problem	5	5
Adverse Event Without Identified Device or Use Problem	3	3
Defective Device	3	3
Loose or Intermittent Connection	3	3
Inadequacy of Device Shape and/or Size	2	2
Fitting Problem	2	2
Unintended Movement	2	2
No Apparent Adverse Event	1	1
Intermittent Loss of Power	1	1
Activation Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Blocked Connection	1	1
Detachment of Device or Device Component	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Defective Component	1	1
Dull, Blunt	1	1
Failure to Align	1	1
Failure to Disconnect	1	1
Smoking	1	1
Misconnection	1	1
No Device Output	1	1
Failure to Power Up	1	1
Inability to Irrigate	1	1
Crack	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	728	728
No Consequences Or Impact To Patient	176	176
No Known Impact Or Consequence To Patient	18	18
No Patient Involvement	11	11
Unintended Radiation Exposure	8	8
Insufficient Information	7	7
Radiation Exposure, Unintended	7	7
Device Embedded In Tissue or Plaque	7	7
Unspecified Tissue Injury	5	5
Foreign Body In Patient	3	3
Bone Fracture(s)	3	3
Oversedation	2	2
Burn(s)	2	2
Eye Injury	2	2
Burn, Thermal	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Xomed, Inc.	II	Oct-21-2021