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	89	89
Device Slipped	84	84
Loose or Intermittent Connection	53	53
Positioning Problem	42	42
Deformation Due to Compressive Stress	39	39
Physical Resistance/Sticking	37	37
Mechanics Altered	30	30
Break	30	30
Device Handling Problem	28	28
Positioning Failure	19	19
Adverse Event Without Identified Device or Use Problem	17	17
Fitting Problem	17	17
Leak/Splash	16	16
Mechanical Jam	14	14
Decrease in Pressure	13	13
Naturally Worn	12	12
Material Integrity Problem	12	12
Connection Problem	9	9
Fluid/Blood Leak	8	8
Material Twisted/Bent	6	6
Detachment of Device or Device Component	6	6
Difficult to Open or Close	6	6
Defective Device	6	6
Component Missing	6	6
Material Deformation	5	5
Insufficient Information	5	5
Device Dislodged or Dislocated	4	4
Low Readings	3	3
Delivered as Unsterile Product	3	3
Noise, Audible	3	3
Use of Device Problem	3	3
Failure to Cut	3	3
Material Separation	2	2
Contamination /Decontamination Problem	2	2
Failure to Clean Adequately	2	2
Failure to Eject	2	2
Material Fragmentation	2	2
Packaging Problem	2	2
Device-Device Incompatibility	2	2
Material Split, Cut or Torn	2	2
Fracture	2	2
Problem with Removal of Enzymatic Cleaner	2	2
Material Frayed	1	1
Material Too Rigid or Stiff	1	1
Overheating of Device	1	1
Battery Problem	1	1
Explosion	1	1
Patient-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	423	423
No Known Impact Or Consequence To Patient	256	256
No Patient Involvement	106	106
No Consequences Or Impact To Patient	88	88
Laceration(s)	24	24
Insufficient Information	21	21
No Information	13	13
Injury	7	7
Abrasion	5	5
Pain	3	3
Bruise/Contusion	3	3
Fall	3	3
Neck Pain	2	2
Neck Stiffness	2	2
Needle Stick/Puncture	2	2
Concussion	2	2
Multiple Fractures	2	2
Blister	2	2
Bone Fracture(s)	2	2
Head Injury	2	2
Hemorrhage/Bleeding	2	2
Fasciitis	1	1
Skin Tears	1	1
Ambulation Difficulties	1	1
Necrosis	1	1
Nerve Damage	1	1
Paresis	1	1
Septic Shock	1	1
Swelling	1	1
Limb Fracture	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Airway Obstruction	1	1
Bacterial Infection	1	1
Cellulitis	1	1
Erythema	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