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
2018	145	145
2019	129	166
2020	119	144
2021	130	196
2022	90	132

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	209	209
Pressure Problem	94	94
Decrease in Pressure	92	263
Deflation Problem	49	49
Air Leak	35	35
Leak/Splash	32	32
Inflation Problem	31	31
Material Split, Cut or Torn	17	17
Delivered as Unsterile Product	12	12
Device Alarm System	11	11
Break	9	9
Material Puncture/Hole	9	9
Output Problem	9	9
Infusion or Flow Problem	9	9
Therapeutic or Diagnostic Output Failure	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Product Quality Problem	6	6
Device Emits Odor	6	6
Material Frayed	6	6
Patient Device Interaction Problem	6	6
Increase in Pressure	5	5
Self-Activation or Keying	5	5
Appropriate Term/Code Not Available	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Device Operates Differently Than Expected	4	4
Use of Device Problem	4	4
Calibration Problem	4	4
Material Integrity Problem	3	3
Battery Problem	3	3
Electromagnetic Interference	3	3
Unintended Deflation	3	3
Hole In Material	2	2
Fluid/Blood Leak	2	2
Difficult to Remove	2	2
Incorrect Measurement	2	2
No Apparent Adverse Event	2	2
No Pressure	2	2
Protective Measures Problem	2	2
Component Missing	2	2
Radiofrequency Interference (RFI)	2	2
Device Displays Incorrect Message	2	2
Patient-Device Incompatibility	1	1
Device Sensing Problem	1	1
Failure to Shut Off	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Improper Alarm	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Device Issue	1	1
Split	1	1
Defective Device	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Device Markings/Labelling Problem	1	1
Power Problem	1	1
Operating System Becomes Nonfunctional	1	1
Material Twisted/Bent	1	1
Naturally Worn	1	1
Insufficient Information	1	1
Torn Material	1	1
Noise, Audible	1	1
No Device Output	1	1
Overheating of Device	1	1
Loss of Power	1	1
Unable to Obtain Readings	1	1
Smoking	1	1
Problem with Sterilization	1	1
Stretched	1	1
Device Inoperable	1	1
Image Display Error/Artifact	1	1
Excess Flow or Over-Infusion	1	0
Electrical /Electronic Property Problem	1	1
Low Audible Alarm	1	1
Thermal Decomposition of Device	1	1
Use of Incorrect Control/Treatment Settings	1	1
Crack	1	1
Degraded	1	1
No Display/Image	1	1
Display or Visual Feedback Problem	1	1
Key or Button Unresponsive/not Working	1	1
Sharp Edges	1	1
Device Fell	1	1
Unexpected Shutdown	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	214	345
No Consequences Or Impact To Patient	191	246
No Known Impact Or Consequence To Patient	92	99
No Patient Involvement	79	102
Insufficient Information	21	46
Blood Loss	16	16
No Code Available	14	14
Skin Discoloration	5	5
Hematoma	4	4
Blister	4	4
Numbness	4	4
No Information	3	3
Bruise/Contusion	3	3
Burn(s)	2	2
Missing Value Reason	2	2
Swelling/ Edema	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Tissue Breakdown	1	1
Foreign Body In Patient	1	1
Patient Problem/Medical Problem	1	1
Cyanosis	1	1
Ecchymosis	1	1
Tingling	1	1
Discharge	1	1
Hemorrhage/Bleeding	1	1
Unspecified Infection	1	1
Irritation	1	1
Laceration(s)	1	1
Pain	1	1
Loss of Range of Motion	1	1
Rash	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Delfi Medical Innovations, Inc.	II	May-06-2020
2	Stryker Instruments Div. of Stryker Corporation	II	Dec-02-2019
3	Stryker Sustainability Solutions	II	Feb-22-2022
4	Stryker Sustainability Solutions	II	Apr-27-2020
5	Zimmer Surgical Inc	II	Jan-28-2020
6	Zimmer Surgical Inc	II	Feb-14-2018