Staple, Removable (skin)

Device Code: 5636

Product Code(s): GDT

Device Type ID	5636
Device Name	Staple, Removable (skin)
Regulation Description	Removable Skin Staple.
Regulation Medical Specialty	General & Plastic Surgery
Review Panel	General & Plastic Surgery
Premarket Review	Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type	510(K) Exempt
CFR Regulation Number	878.4760 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	GDT
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Problems
Mechanical Jam	720
Failure To Form Staple	190
Misfire	61
Tear, Rip Or Hole In Device Packaging	59
Unsealed Device Packaging	42
Delivered As Unsterile Product	33
Difficult To Open Or Close	33
Loss Of Or Failure To Bond	29
Activation, Positioning Or Separation Problem	23
Premature Activation	22
Entrapment Of Device	20
Break	15
Mechanical Problem	13
Adverse Event Without Identified Device Or Use Problem	13
Difficult Or Delayed Positioning	10
Failure To Align	10
Loose Or Intermittent Connection	10
Unintended Movement	10
Failure To Fire	7
Difficult To Remove	5
Component Missing	4
Positioning Failure	4
Separation Failure	3
Device Damaged Prior To Use	3
Detachment Of Device Or Device Component	3
Device Operates Differently Than Expected	3
Patient-Device Incompatibility	2
Bent	2
Failure To Cycle	2
Unintended Ejection	2
Packaging Problem	2
Insufficient Information	2
Environmental Particulates	2
Detachment Of Device Component	1
Sticking	1
Material Deformation	1
Defective Device	1
Device Slipped	1
Mechanics Altered	1
Premature Separation	1
Use Of Device Problem	1
Appropriate Term/Code Not Available	1
Invalid Sensing	1
Staple	1
Failure To Adhere Or Bond	1
Total Device Problems	1371

TPLC Last Update: 2019-04-02 21:09:54