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	19	19
Therapeutic or Diagnostic Output Failure	12	12
Failure to Sense	12	12
Loss of or Failure to Bond	8	8
Break	7	7
Loose or Intermittent Connection	7	7
Device Sensing Problem	6	6
Device Dislodged or Dislocated	4	4
Unintended Movement	3	3
Defective Component	3	3
Component Missing	2	2
Device Displays Incorrect Message	2	2
Device Slipped	2	2
Disconnection	2	2
Migration	2	2
Device Markings/Labelling Problem	2	2
Protective Measures Problem	2	2
Device Alarm System	1	1
Gas/Air Leak	1	1
Improper Flow or Infusion	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Output Problem	1	1
Positioning Problem	1	1
Premature Separation	1	1
Ventilation Problem in Device Environment	1	1
Insufficient Information	1	1
Material Disintegration	1	1
Entrapment of Device	1	1
Material Fragmentation	1	1
Leak/Splash	1	1
Material Puncture/Hole	1	1
Product Quality Problem	1	1
Material Discolored	1	1
Use of Device Problem	1	1
Device Damaged Prior to Use	1	1
Material Separation	1	1
Connection Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	36	36
No Clinical Signs, Symptoms or Conditions	29	29
Insufficient Information	8	8
Vomiting	7	7
Foreign Body In Patient	7	7
Low Oxygen Saturation	3	3
No Consequences Or Impact To Patient	2	2
Unspecified Tissue Injury	2	2
No Information	1	1
Pressure Sores	1	1
Hemorrhage/Bleeding	1	1
High Blood Pressure/ Hypertension	1	1
Low Blood Pressure/ Hypotension	1	1
Laceration(s)	1	1
Necrosis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CooperSurgical, Inc.	II	Nov-10-2022