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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tourniquet, pneumatic
Product CodeKCY
Regulation Number 878.5910
Device Class 1


Premarket Reviews
ManufacturerDecision
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 6 35

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 250 250
Gas/Air Leak 221 221
Decrease in Pressure 150 653
Pressure Problem 65 65
Deflation Problem 49 49
Inflation Problem 31 31
Delivered as Unsterile Product 16 16
Material Split, Cut or Torn 15 15
Output Problem 11 11
Increase in Pressure 10 13
Material Puncture/Hole 9 9
Break 9 9
Infusion or Flow Problem 9 9
Therapeutic or Diagnostic Output Failure 8 8
Device Alarm System 8 8
Incorrect, Inadequate or Imprecise Result or Readings 7 7
No Apparent Adverse Event 7 7
Patient Device Interaction Problem 7 7
Material Frayed 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
Electromagnetic Interference 3 3
Self-Activation or Keying 3 3
No Pressure 3 3
Measurement System Incompatibility 3 3
Protective Measures Problem 3 3
Appropriate Term/Code Not Available 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
Noise, Audible 2 2
Insufficient Information 2 2
Battery Problem 2 2
Thermal Decomposition of Device 2 2
Computer Software Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Crack 1 1
Degraded 1 1
No Display/Image 1 1
Display or Visual Feedback Problem 1 1
Electrical /Electronic Property Problem 1 1
Low Audible Alarm 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
Naturally Worn 1 1
Operating System Becomes Nonfunctional 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 549 1015
No Consequences Or Impact To Patient 100 155
No Known Impact Or Consequence To Patient 69 76
No Patient Involvement 65 88
Insufficient Information 41 271
Blood Loss 5 5
Blister 5 5
Skin Discoloration 5 5
Hemorrhage/Bleeding 5 5
Numbness 4 4
No Code Available 3 3
Bruise/Contusion 3 3
Burn(s) 2 2
Missing Value Reason 2 2
Hematoma 2 2
Swelling/ Edema 1 1
Convulsion/Seizure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
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

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
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