TPLC - Total Product Life Cycle

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Device	operating room accessories table tray
Regulation Description	Manual operating table and accessories and manual operating chair and accessories.
Definition	This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product Code	FWZ
Regulation Number	878.4950
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	302	302
Unintended Movement	95	95
Unstable	94	94
Device Slipped	90	90
Loose or Intermittent Connection	53	53
Positioning Problem	42	42
Deformation Due to Compressive Stress	39	39
Physical Resistance/Sticking	37	37
Mechanics Altered	32	32
Break	32	32
Device Handling Problem	29	29
Positioning Failure	19	19
Fitting Problem	17	17
Adverse Event Without Identified Device or Use Problem	17	17
Leak/Splash	16	16
Mechanical Jam	14	14
Decrease in Pressure	13	13
Material Integrity Problem	12	12
Naturally Worn	12	12
Connection Problem	9	9
Fluid/Blood Leak	8	8
Detachment of Device or Device Component	7	7
Difficult to Open or Close	6	6
Defective Device	6	6
Material Twisted/Bent	6	6
Component Missing	6	6
Material Deformation	5	5
Insufficient Information	5	5
Device Dislodged or Dislocated	4	4
Delivered as Unsterile Product	3	3
Failure to Cut	3	3
Low Readings	3	3
Use of Device Problem	3	3
Noise, Audible	3	3
Contamination /Decontamination Problem	2	2
Device-Device Incompatibility	2	2
Degraded	2	2
Problem with Removal of Enzymatic Cleaner	2	2
Fracture	2	2
Material Fragmentation	2	2
Failure to Clean Adequately	2	2
Packaging Problem	2	2
Material Separation	2	2
Failure to Eject	2	2
Material Split, Cut or Torn	2	2
Overheating of Device	1	1
Nonstandard Device	1	1
Device Fell	1	1
Material Puncture/Hole	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	435	435
No Known Impact Or Consequence To Patient	256	256
No Patient Involvement	106	106
No Consequences Or Impact To Patient	88	88
Laceration(s)	28	28
Insufficient Information	22	22
No Information	13	13
Injury	7	7
Abrasion	5	5
Fall	4	4
Bruise/Contusion	3	3
Pain	3	3
Bacterial Infection	2	2
Bone Fracture(s)	2	2
Head Injury	2	2
Hemorrhage/Bleeding	2	2
Neck Pain	2	2
Neck Stiffness	2	2
Needle Stick/Puncture	2	2
Multiple Fractures	2	2
Blister	2	2
Concussion	2	2
Airway Obstruction	1	1
Cellulitis	1	1
Erythema	1	1
Fasciitis	1	1
Skin Tears	1	1
Ambulation Difficulties	1	1
Limb Fracture	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Necrosis	1	1
Nerve Damage	1	1
Paresis	1	1
Septic Shock	1	1
Swelling	1	1
Convulsion/Seizure	1	1
Unspecified Respiratory Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Mar-12-2024