TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Intermittent Loss of Power	124	525
Mechanical Jam	93	289
Unintended System Motion	90	507
Electrical /Electronic Property Problem	89	270
Grounding Malfunction	63	161
Mechanical Problem	58	149
Unintended Movement	31	88
Fluid/Blood Leak	28	178
Sharp Edges	26	38
Positioning Failure	14	16
Device Fell	12	12
Device Slipped	11	14
Insufficient Information	8	8
Break	7	7
Device Stops Intermittently	5	8
Patient Device Interaction Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Device Operates Differently Than Expected	4	4
Defective Component	3	3
Peeled/Delaminated	2	2
No Audible Alarm	2	2
Fire	2	2
Unintended Electrical Shock	2	2
Leak/Splash	1	1
Incorrect Measurement	1	1
Loss of or Failure to Bond	1	1
Migration or Expulsion of Device	1	1
Device Inoperable	1	1
Use of Device Problem	1	1
Smoking	1	1
Component Missing	1	1
Failure to Align	1	1
Arcing	1	1
Battery Problem	1	1
Output Problem	1	1
Positioning Problem	1	3
Material Integrity Problem	1	1
No Apparent Adverse Event	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	380	1521
No Patient Involvement	188	670
Insufficient Information	39	64
Pain	19	26
Injury	13	13
Muscle/Tendon Damage	9	25
No Consequences Or Impact To Patient	7	19
Fall	7	11
Laceration(s)	6	6
Electric Shock	5	11
Bruise/Contusion	4	19
Bone Fracture(s)	2	2
Shock	2	4
No Known Impact Or Consequence To Patient	2	4
No Information	1	1
No Code Available	1	1
Unspecified Musculoskeletal problem	1	4
Sprain	1	1
Concussion	1	1
Head Injury	1	1
Fatigue	1	1
Joint Dislocation	1	1
Neck Pain	1	1
Muscle Spasm(s)	1	1
Discomfort	1	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Medical Division of Stryker Corporation	II	Jun-01-2020
2	Stryker Medical Division of Stryker Corporation	II	Mar-17-2016