TPLC - Total Product Life Cycle

show TPLC since

Premarket Reviews
Manufacturer	Decision
MCEWEN AND ASSOCIATES CONSULTING LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	266	266
Decrease in Pressure	206	796
Gas/Air Leak	156	156
Pressure Problem	71	71
Delivered as Unsterile Product	48	48
Measurement System Incompatibility	42	42
Deflation Problem	42	42
Inflation Problem	30	30
Increase in Pressure	20	31
Material Split, Cut or Torn	12	12
Patient Device Interaction Problem	12	12
No Apparent Adverse Event	11	11
Output Problem	11	11
Packaging Problem	11	11
Device Alarm System	10	10
Material Puncture/Hole	9	9
Infusion or Flow Problem	9	9
Use of Device Problem	8	8
Therapeutic or Diagnostic Output Failure	7	7
Product Quality Problem	6	6
Break	6	6
Calibration Problem	6	6
Component Missing	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	7
Noise, Audible	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Material Frayed	5	5
Expiration Date Error	5	5
Application Program Version or Upgrade Problem	5	5
Manufacturing, Packaging or Shipping Problem	4	4
Incorrect Measurement	4	4
Self-Activation or Keying	3	3
Electromagnetic Interference	3	3
Protective Measures Problem	3	3
Computer Software Problem	3	3
Unintended Deflation	3	3
Radiofrequency Interference (RFI)	2	2
Intermittent Loss of Power	2	2
Display or Visual Feedback Problem	2	2
Appropriate Term/Code Not Available	2	2
Detachment of Device or Device Component	2	2
Material Deformation	2	2
Patient-Device Incompatibility	2	2
Insufficient Information	2	2
Charging Problem	2	2
Thermal Decomposition of Device	2	2
Defective Device	2	2
No Pressure	2	2
Battery Problem	2	2
Difficult to Remove	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	728	1322
Insufficient Information	79	421
No Consequences Or Impact To Patient	50	70
No Patient Involvement	30	30
No Known Impact Or Consequence To Patient	23	24
Blister	8	8
Bruise/Contusion	6	8
Skin Discoloration	5	5
Hemorrhage/Bleeding	5	5
Blood Loss	4	4
Numbness	4	4
Pain	4	4
Swelling/ Edema	4	4
No Code Available	2	2
Hematoma	2	2
Erythema	2	2
Cyanosis	1	1
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Tingling	1	1
Exsanguination	1	1
Localized Skin Lesion	1	1
Burn(s)	1	1
Irritation	1	1
Rash	1	1
Ecchymosis	1	1
Laceration(s)	1	1
Muscle/Tendon Damage	1	1
Discharge	1	1
Convulsion/Seizure	1	1
Tissue Breakdown	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Delfi Medical Innovations, Inc.	II	May-06-2020
2	Stryker Corporation	II	Aug-07-2025
3	Stryker Corporation	II	Apr-04-2023
4	Stryker Sustainability Solutions	II	Jul-17-2024
5	Stryker Sustainability Solutions	II	Apr-01-2023
6	Stryker Sustainability Solutions	II	Feb-22-2022
7	Stryker Sustainability Solutions	II	Apr-27-2020
8	Zimmer Surgical Inc	II	Jan-28-2020