Staple, Implantable

Device Code: 5637

Product Code(s): GDW

Device Classification Information

Device Type ID	5637
Device Name	Staple, Implantable
Regulation Description	Implantable 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)
CFR Regulation Number	878.4750 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	GDW
GMP Exempt	No
Summary MR	Ineligible
Implanted Device	Yes
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID	5637
Device	Staple, Implantable
Product Code	GDW
FDA Device Classification	Class 2 Medical Device
Regulation Description	Implantable Staple.
CFR Regulation Number	878.4750 [🔎]

Premarket Reviews
Manufacturer	Decision
C.R. BARD INC.
	SUBSTANTIALLY EQUIVALENT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	3
CARDICA, INC.
	SUBSTANTIALLY EQUIVALENT	5
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	7
COVIDIEN LLC
	SUBSTANTIALLY EQUIVALENT	4
DEXTERA SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	6
ETHICON
	SUBSTANTIALLY EQUIVALENT	7
ETHICON ENDO-SURGERY, LLC
	SUBSTANTIALLY EQUIVALENT	1
ETHICON ENDO-SURGERY, INC.
	SUBSTANTIALLY EQUIVALENT	1
ETHICON ENDO-SURGERY, LLC
	SUBSTANTIALLY EQUIVALENT	6
EZISURG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
GOLDEN STAPLER SURGICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JUSTRIGHT SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
LEXINGTON MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
OPUS KSD, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGIMATIX, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU BEINUO MEDICAL EQUIPMENT CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
VIA SURGICAL LTD.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
Failure To Fire	10593
Failure To Form Staple	3476
Misfire	2988
Difficult To Open Or Close	1872
Human-Device Interface Problem	1332
Noise, Audible	1285
Adverse Event Without Identified Device Or Use Problem	1284
Break	1142
Entrapment Of Device	1106
Detachment Of Device Component	813
Mechanics Altered	738
Failure To Adhere Or Bond	643
Difficult To Remove	403
Device Displays Incorrect Message	401
Detachment Of Device Or Device Component	394
Failure To Cycle	303
Fluid Leak	284
Failure To Cut	272
Device Operates Differently Than Expected	259
Retraction Problem	201
Device Difficult To Setup Or Prepare	198
Difficult Or Delayed Positioning	193
Expulsion	166
Unintended Movement	165
Loss Of Or Failure To Bond	165
Device Inoperable	158
Component Or Accessory Incompatibility	142
Bent	140
Use Of Device Problem	118
Mechanical Jam	118
Positioning Problem	113
Mechanical Problem	109
Physical Resistance	103
Insufficient Information	95
Failure To Sense	92
Positioning Failure	90
Air Leak	86
Device Stops Intermittently	86
Appropriate Term/Code Not Available	77
Device Slipped	71
Difficult To Position	69
Failure To Read Input Signal	64
Unintended System Motion	63
Failure To Align	60
Difficult To Advance	56
Fail-Safe Problem	55
Leak / Splash	52
Unintended Arm Motion	51
Failure To Advance	50
Sticking	44
Separation Failure	44
Jaw	41
Component Missing	40
Calibration Problem	40
Gas Leak	39
Material Twisted / Bent	33
Unintended Head Motion	33
Difficult Or Delayed Activation	31
Failure To Calibrate	30
Failure To Charge	29
Staple	28
Knife	27
Complete Loss Of Power	25
Material Deformation	25
Difficult To Insert	24
Power Problem	24
Calibration Error	19
Component Falling	19
Overheating Of Device	18
Extrusion	18
Physical Resistance / Sticking	17
Protective Measures Problem	17
Material Separation	16
Packaging Problem	16
Activation, Positioning Or Separation Problem	15
Product Quality Problem	14
Tear, Rip Or Hole In Device Packaging	13
Device Contamination With Chemical Or Other Material	13
Device Packaging Compromised	11
Device Handling Problem	11
Switch, Push Button	11
Material Fragmentation	10
Knob	10
Improper Or Incorrect Procedure Or Method	10
Device Remains Activated	10
Contamination / Decontamination Problem	9
Migration Or Expulsion Of Device	9
Failure To Power Up	9
Premature End-of-Life Indicator	9
Defective Device	9
Premature Activation	9
Display Or Visual Feedback Problem	9
Device Damaged Prior To Use	8
Self-Activation Or Keying	8
Backflow	7
Handpiece	7
Incorrect, Inadequate Or Imprecise Result Or Readings	7
Clip	7
Material Protrusion / Extrusion	7
Misassembly By Users	6
Total Device Problems	33739

Recalls
Manufacturer		Recall Class	Date Posted
1	COVIDIEN MEDTRONIC	II	Jul-19-2018
2	COVIDIEN MEDTRONIC	II	May-16-2018
3	Cardica, Inc.	II	Dec-24-2015
4	Covidien LLC	II	Apr-26-2018
5	Covidien LLC	II	Mar-27-2018
6	Covidien LLC	II	Mar-06-2018
7	Covidien LLC	II	Feb-16-2018
8	EXP Pharmaceutical Services Corp	II	Jul-24-2015
9	Ethicon Endo-Surgery Inc	II	Jan-08-2019
10	Ethicon Endo-Surgery Inc	II	Feb-21-2018
11	Ethicon Endo-Surgery Inc	II	May-31-2017
12	Ethicon Endo-Surgery Inc	II	Oct-20-2016
13	Ethicon Endo-Surgery Inc	II	May-21-2015
14	Incisive Surgical Inc	II	Oct-05-2018
15	Incisive Surgical Inc	II	Apr-29-2015
16	Intuitive Surgical, Inc.	II	Jul-06-2018
17	Justright Surgical, LLC	II	Jul-02-2015
18	Justright Surgical, LLC	II	Sep-23-2014
19	Laax, Inc.	I	Apr-23-2015
20	Medtronic	II	Feb-18-2016

TPLC Last Update: 2019-04-02 21:09:58