TPLC - Total Product Life Cycle

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Device	apparatus, exhaust, surgical
Regulation Description	Air-handling apparatus for a surgical operating room.
Product Code	FYD
Regulation Number	878.5070
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult or Delayed Activation	62	62
Adverse Event Without Identified Device or Use Problem	13	13
Noise, Audible	9	9
Ventilation Problem in Device Environment	9	9
Electrical Shorting	6	6
Arcing of Electrodes	6	6
Appropriate Device Problem Term/Code Not Available	6	6
Self-Activation or Keying	3	3
Flaked	2	2
Fire	2	2
Break	2	2
Intermittent Energy Output	2	2
Failure to Calibrate	2	2
Smoking	2	2
Material Separation	1	1
Material Integrity Problem	1	1
Computer Software Problem	1	1
Unintended Power Up	1	1
Physical Resistance/Sticking	1	1
Human-Device Interface Problem	1	1
Overheating of Device	1	1
Arcing at Paddles	1	1
Fumes or Vapors	1	1
Failure to Fire	1	1
Premature Activation	1	1
Electrical Power Problem	1	1
Fluid/Blood Leak	1	1
Communication or Transmission Problem	1	1
Detachment of Device or Device Component	1	1
Suction Problem	1	1
Unintended Electrical Shock	1	1
Device Displays Incorrect Message	1	1
Activation Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	87	87
Insufficient Information	9	9
Partial thickness (Second Degree) Burn	5	5
Burn(s)	2	2
Hemorrhage/Blood Loss/Bleeding	2	2
Burning Sensation	1	1
Blister	1	1
Foreign Body In Patient	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Superficial (First Degree) Burn	1	1
Rash	1	1
Skin Burning Sensation	1	1
Medical device site infection	1	1
Scar Tissue	1	1
Unspecified Tissue Injury	1	1
Caustic/Chemical Burns	1	1
Full thickness (Third Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022
2	SurgiSmoke Solutions	II	Apr-22-2026