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TPLC
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Device
staple, implantable
Product Code
GDW
Regulation Number
878.4750
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANIKA THERAPEUTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
APPLIED MEDICAL RESOURCES CORPORATION
SUBSTANTIALLY EQUIVALENT
1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD
SUBSTANTIALLY EQUIVALENT
1
COVIDIEN
SUBSTANTIALLY EQUIVALENT
17
DATASCOPE CORP.
SUBSTANTIALLY EQUIVALENT
1
DAVOL INC., SUBSIDIARY OF C.R. BARD
SUBSTANTIALLY EQUIVALENT
1
ETHICON ENDO-SURGERY
SUBSTANTIALLY EQUIVALENT
1
ETHICON ENDO-SURGERY LLC
SUBSTANTIALLY EQUIVALENT
1
ETHICON ENDO-SURGERY, LLC
SUBSTANTIALLY EQUIVALENT
4
EZISURG (SUZHOU) MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
EZISURG MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
FENGH MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
LEXINGTON MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
3
LEXINGTON MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
SUBSTANTIALLY EQUIVALENT
1
NINGBO VERYKIND MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
REACH SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
STANDARD BARIATRICS
SUBSTANTIALLY EQUIVALENT
1
SURGIMATIX, INC.
SUBSTANTIALLY EQUIVALENT
1
VIA SURGICAL LTD.
SUBSTANTIALLY EQUIVALENT
2
VIEWPOINT MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
WUXI BEIEN SURGERY DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
14913
14913
2019
16597
16597
2020
12327
12327
2021
13015
13015
2022
13607
13607
2023
9815
9815
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Fire
29449
29449
Failure to Form Staple
12866
12866
Misfire
8621
8621
Adverse Event Without Identified Device or Use Problem
7269
7269
Difficult to Open or Close
7025
7025
Break
4076
4076
Detachment of Device or Device Component
2966
2966
Entrapment of Device
2871
2871
Human-Device Interface Problem
2562
2562
Noise, Audible
2115
2115
Insufficient Information
1993
1993
Firing Problem
1662
1662
Mechanical Jam
1544
1544
Failure to Cut
1493
1493
Complete Loss of Power
1342
1342
Mechanics Altered
1292
1292
Failure to Charge
1191
1191
Loss of or Failure to Bond
1083
1083
Device Displays Incorrect Message
1055
1055
Component or Accessory Incompatibility
921
921
Difficult to Remove
854
854
No Apparent Adverse Event
800
800
Retraction Problem
787
787
Mechanical Problem
620
620
Ejection Problem
600
600
Material Integrity Problem
599
599
Power Problem
532
532
Patient Device Interaction Problem
532
532
Expulsion
518
518
Material Twisted/Bent
421
421
Physical Resistance/Sticking
420
420
Activation Failure
415
415
Difficult or Delayed Positioning
394
394
Fluid/Blood Leak
382
382
Device Difficult to Setup or Prepare
326
326
Corroded
321
321
Detachment Of Device Component
310
310
Activation Problem
304
304
Failure to Align
267
267
Unintended Movement
249
249
Device Markings/Labelling Problem
249
249
Device Slipped
240
240
Device Operates Differently Than Expected
239
239
Positioning Problem
236
236
Positioning Failure
228
228
Failure to Power Up
216
216
Appropriate Term/Code Not Available
214
214
Gas/Air Leak
206
206
Defective Device
203
203
Activation, Positioning or Separation Problem
192
192
Unintended Ejection
181
181
Failure To Adhere Or Bond
178
178
Leak/Splash
176
176
Delivered as Unsterile Product
168
168
Product Quality Problem
159
159
Tear, Rip or Hole in Device Packaging
156
156
Nonstandard Device
147
147
Difficult to Insert
140
140
Device Misassembled During Manufacturing /Shipping
136
136
Component Missing
127
127
Self-Activation or Keying
125
125
Unintended System Motion
125
125
Failure to Read Input Signal
124
124
Failure to Advance
117
117
Material Separation
102
102
No Display/Image
97
97
Failure to Eject
95
95
Material Protrusion/Extrusion
92
92
Overheating of Device
86
86
Device Inoperable
83
83
Loose or Intermittent Connection
82
82
Manufacturing, Packaging or Shipping Problem
81
81
Failure to Cycle
80
80
Electrical /Electronic Property Problem
77
77
Battery Problem
77
77
Separation Problem
76
76
Separation Failure
73
73
Device Fell
72
72
Therapeutic or Diagnostic Output Failure
72
72
Fail-Safe Problem
70
70
Use of Device Problem
70
70
Incorrect, Inadequate or Imprecise Result or Readings
67
67
Premature End-of-Life Indicator
65
65
Material Fragmentation
65
65
Material Deformation
65
65
Difficult to Advance
64
64
Difficult or Delayed Activation
63
63
Patient-Device Incompatibility
60
60
Structural Problem
59
59
Computer Software Problem
59
59
Bent
56
56
No Device Output
55
55
Device Contamination with Chemical or Other Material
55
55
Protective Measures Problem
55
55
Defective Component
53
53
Unraveled Material
48
48
Excessive Heating
48
48
Calibration Problem
45
45
Output Problem
44
44
Packaging Problem
42
42
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
28676
28676
No Consequences Or Impact To Patient
21364
21364
No Known Impact Or Consequence To Patient
11569
11569
No Code Available
6722
6723
Unspecified Tissue Injury
4284
4284
Insufficient Information
3671
3671
Failure to Anastomose
3217
3217
Hemorrhage/Bleeding
2297
2297
Tissue Damage
1824
1824
Blood Loss
1392
1393
No Information
1329
1329
No Patient Involvement
1231
1231
Pain
496
496
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
451
451
Fistula
443
443
Unspecified Infection
351
351
Abscess
302
302
Sepsis
269
269
Hematoma
268
268
Foreign Body In Patient
263
263
Abdominal Pain
238
238
Fever
234
234
Death
228
229
Injury
228
228
Obstruction/Occlusion
225
225
Peritonitis
166
166
Tissue Breakdown
164
164
Hernia
157
157
Unintended Radiation Exposure
145
145
Radiation Exposure, Unintended
133
133
Inflammation
131
131
Not Applicable
129
129
Laceration(s)
126
126
Wound Dehiscence
121
121
Post Operative Wound Infection
119
119
Vomiting
115
115
Seroma
106
106
Tachycardia
98
98
Nausea
89
89
Pleural Effusion
87
87
Septic Shock
78
78
Low Blood Pressure/ Hypotension
75
75
Pneumothorax
74
74
Pneumonia
73
73
Adhesion(s)
72
72
Bowel Perforation
70
70
Incontinence
68
68
Device Embedded In Tissue or Plaque
67
67
Stenosis
65
65
Perforation
61
61
Anemia
60
60
Necrosis
58
58
Pulmonary Emphysema
55
55
Urinary Tract Infection
50
50
Impaired Healing
50
50
Diarrhea
49
49
Fluid Discharge
48
48
Abdominal Distention
46
46
Urinary Retention
46
46
Cardiac Arrest
44
44
Exsanguination
43
43
High Blood Pressure/ Hypertension
43
43
Thrombosis
39
39
Thrombosis/Thrombus
39
39
Ulcer
39
39
Renal Failure
38
38
Bacterial Infection
38
38
Dyspnea
37
37
Ischemia
37
37
Pulmonary Embolism
33
33
Respiratory Failure
31
31
Purulent Discharge
30
30
Perforation of Vessels
29
29
Unspecified Respiratory Problem
29
29
Swelling/ Edema
28
28
Ascites
27
27
Discomfort
26
26
Shock
25
25
Distress
22
22
Organ Dehiscence
22
22
Rectal Anastomotic Leakage
22
22
Failure of Implant
21
21
Dehydration
21
21
Myocardial Infarction
20
20
Swelling
19
19
Scar Tissue
16
16
Muscle Weakness
16
16
Hypoxia
16
16
Dysphagia/ Odynophagia
16
16
Fibrosis
16
16
Cancer
15
15
Itching Sensation
15
15
Chest Pain
14
14
Emotional Changes
13
13
Hemostasis
13
13
Internal Organ Perforation
13
13
Syncope/Fainting
13
13
Weight Changes
13
13
Chills
13
13
Anxiety
12
12
Recalls
Manufacturer
Recall Class
Date Posted
1
COVIDIEN LLC
II
Feb-18-2020
2
COVIDIEN MEDTRONIC
II
Jul-19-2018
3
COVIDIEN MEDTRONIC
II
May-16-2018
4
Covidien LLC
II
Jun-16-2019
5
Covidien LLC
II
Apr-26-2018
6
Covidien LLC
II
Mar-27-2018
7
Covidien LLC
II
Mar-06-2018
8
Covidien LLC
II
Feb-16-2018
9
Covidien Llc
II
Apr-13-2021
10
Covidien Llc
II
Dec-29-2020
11
Covidien, LP
II
Mar-06-2023
12
Covidien, LP
II
Apr-09-2021
13
Covidien, LP
II
Oct-01-2020
14
Ethicon Endo-Surgery Inc
II
Aug-19-2021
15
Ethicon Endo-Surgery Inc
I
Oct-29-2019
16
Ethicon Endo-Surgery Inc
I
May-15-2019
17
Ethicon Endo-Surgery Inc
II
Jan-08-2019
18
Ethicon Endo-Surgery Inc
II
Feb-21-2018
19
Incisive Surgical Inc
II
Oct-05-2018
20
Intuitive Surgical, Inc.
II
Jul-06-2018
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