TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	45	45
Suction Problem	8	8
Suction Failure	8	8
Break	4	4
Disconnection	4	4
Leak/Splash	4	4
Material Separation	3	3
Defective Device	3	3
Fitting Problem	3	3
Material Twisted/Bent	3	3
Device Contamination with Chemical or Other Material	3	3
Gas/Air Leak	3	3
Pressure Problem	3	3
Appropriate Term/Code Not Available	3	3
Material Rupture	2	2
Noise, Audible	2	2
Key or Button Unresponsive/not Working	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Integrity Problem	2	2
Fluid/Blood Leak	2	2
Filling Problem	2	2
Decrease in Suction	2	2
Backflow	1	1
Unintended Ejection	1	1
Burst Container or Vessel	1	1
Complete Blockage	1	1
Detachment Of Device Component	1	1
Failure to Conduct	1	1
Crack	1	1
Inability to Irrigate	1	1
Use of Device Problem	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Nonstandard Device	1	1
Energy Output Problem	1	1
Product Quality Problem	1	1
Difficult to Remove	1	1
No Flow	1	1
Output Problem	1	1
Device Dislodged or Dislocated	1	1
Defective Component	1	1
Component Missing	1	1
Failure to Advance	1	1
Failure to Cut	1	1
Contamination /Decontamination Problem	1	1
Connection Problem	1	1
Insufficient Flow or Under Infusion	1	1
Separation Problem	1	1
Device Handling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	73	73
No Consequences Or Impact To Patient	23	23
No Known Impact Or Consequence To Patient	14	14
No Patient Involvement	6	6
No Information	5	5
Insufficient Information	2	2
Foreign Body In Patient	1	1
Blood Loss	1	1
Pulmonary Embolism	1	1
Death	1	1
Pulmonary Emphysema	1	1
Hemorrhage/Bleeding	1	1
Swelling	1	1
Vitreous Hemorrhage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Minimally Invasive Therapies Group	II	Mar-05-2018