TPLC - Total Product Life Cycle

• Device: tourniquet, pneumatic
• Product Code: KCY
• Regulation Number: 878.5910
• Device Class: 1

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

MDR Year	MDR Reports	MDR Events
2019	129	166
2020	119	144
2021	130	196
2022	90	132
2023	347	653
2024	31	80

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	251	251
Gas/Air Leak	221	221
Decrease in Pressure	157	678
Pressure Problem	65	65
Deflation Problem	49	49
Inflation Problem	31	31
Delivered as Unsterile Product	23	23
Material Split, Cut or Torn	15	15
Measurement System Incompatibility	12	12
Increase in Pressure	12	17
Output Problem	11	11
Infusion or Flow Problem	9	9
Material Puncture/Hole	9	9
Break	9	9
Device Alarm System	8	8
Therapeutic or Diagnostic Output Failure	8	8
No Apparent Adverse Event	7	7
Patient Device Interaction Problem	7	7
Material Frayed	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Use of Device Problem	6	6
Product Quality Problem	6	6
Calibration Problem	5	5
Manufacturing, Packaging or Shipping Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Incorrect Measurement	4	4
Computer Software Problem	3	3
Electromagnetic Interference	3	3
Self-Activation or Keying	3	3
No Pressure	3	3
Protective Measures Problem	3	3
Appropriate Term/Code Not Available	3	3
Noise, Audible	3	3
Material Integrity Problem	3	3
Unintended Deflation	3	3
Intermittent Loss of Power	2	2
Material Deformation	2	2
Defective Device	2	2
Charging Problem	2	2
Difficult to Remove	2	2
Radiofrequency Interference (RFI)	2	2
Insufficient Information	2	2
Battery Problem	2	2
Use of Incorrect Control/Treatment Settings	2	2
Thermal Decomposition of Device	2	2
Low Audible Alarm	1	1
Degraded	1	1
No Display/Image	1	1
Display or Visual Feedback Problem	1	1
Crack	1	1
Electrical /Electronic Property Problem	1	1
Excess Flow or Over-Infusion	1	0
Problem with Sterilization	1	1
Stretched	1	1
Inappropriate Audible Prompt/Feedback	1	1
Defective Component	1	1
Component Missing	1	1
Unable to Obtain Readings	1	1
Device Emits Odor	1	1
No Device Output	1	1
Overheating of Device	1	1
Sharp Edges	1	1
Device Fell	1	1
Power Problem	1	1
Operating System Becomes Nonfunctional	1	1
Naturally Worn	1	1
Tear, Rip or Hole in Device Packaging	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Device Markings/Labelling Problem	1	1
Device Sensing Problem	1	1
Failure to Shut Off	1	1
Patient-Device Incompatibility	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Material Twisted/Bent	1	1
Unexpected Shutdown	1	1
Key or Button Unresponsive/not Working	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	571	1057
No Consequences Or Impact To Patient	100	155
No Known Impact Or Consequence To Patient	69	76
No Patient Involvement	65	88
Insufficient Information	44	292
Blood Loss	5	5
Blister	5	5
Skin Discoloration	5	5
Hemorrhage/Bleeding	5	5
Bruise/Contusion	4	4
Numbness	4	4
No Code Available	3	3
Missing Value Reason	2	2
Hematoma	2	2
Burn(s)	2	2
Cyanosis	1	1
Ecchymosis	1	1
Exsanguination	1	1
Unspecified Infection	1	1
Irritation	1	1
Laceration(s)	1	1
Pain	1	1
Rash	1	1
Tingling	1	1
Discharge	1	1
Tissue Breakdown	1	1
Foreign Body In Patient	1	1
Patient Problem/Medical Problem	1	1
Swelling/ Edema	1	1
Convulsion/Seizure	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Delfi Medical Innovations, Inc.	II	May-06-2020
2	Stryker Corporation	II	Apr-04-2023
3	Stryker Instruments Div. of Stryker Corporation	II	Dec-02-2019
4	Stryker Sustainability Solutions	II	Apr-01-2023
5	Stryker Sustainability Solutions	II	Feb-22-2022
6	Stryker Sustainability Solutions	II	Apr-27-2020
7	Zimmer Surgical Inc	II	Jan-28-2020