Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
14
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
3
EZISURG (SUZHOU) MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
EZISURG MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
FENGH MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
LEXINGTON MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
2
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
WUXI BEIEN SURGERY DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
16597
16597
2020
12327
12327
2021
13015
13015
2022
13608
13608
2023
14687
14687
2024
5668
5686
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Fire
27055
27055
Failure to Form Staple
12157
12157
Misfire
7882
7882
Adverse Event Without Identified Device or Use Problem
7607
7607
Difficult to Open or Close
7345
7345
Break
3838
3838
Entrapment of Device
3060
3060
Detachment of Device or Device Component
2951
2951
Insufficient Information
2379
2379
Human-Device Interface Problem
2315
2315
Noise, Audible
1757
1757
Failure to Cut
1465
1465
Mechanical Jam
1447
1447
Complete Loss of Power
1422
1422
Failure to Charge
1238
1238
Device Displays Incorrect Message
1153
1153
Mechanics Altered
1099
1099
Loss of or Failure to Bond
1056
1056
Firing Problem
1048
1048
No Apparent Adverse Event
980
980
Component or Accessory Incompatibility
930
930
Ejection Problem
796
796
Material Integrity Problem
767
767
Difficult to Remove
719
719
Retraction Problem
675
675
Patient Device Interaction Problem
636
654
Power Problem
520
520
Expulsion
517
517
Activation Failure
516
516
Mechanical Problem
496
496
Material Twisted/Bent
408
408
Activation Problem
373
373
Physical Resistance/Sticking
360
360
Corroded
325
325
Difficult or Delayed Positioning
294
294
Device Difficult to Setup or Prepare
292
292
Failure to Align
263
263
Device Markings/Labelling Problem
259
259
Unintended Movement
245
245
Positioning Failure
242
242
Device Slipped
239
239
Unintended Ejection
236
236
Failure to Power Up
227
227
Fluid/Blood Leak
226
226
Delivered as Unsterile Product
205
205
Appropriate Term/Code Not Available
187
187
Difficult to Insert
176
176
Positioning Problem
174
174
Product Quality Problem
163
163
Activation, Positioning or Separation Problem
158
158
Gas/Air Leak
155
155
Tear, Rip or Hole in Device Packaging
151
151
Self-Activation or Keying
151
151
Device Misassembled During Manufacturing /Shipping
148
148
Nonstandard Device
146
146
Defective Device
141
141
Unintended System Motion
139
139
Failure to Read Input Signal
136
136
Computer Software Problem
127
127
Failure to Eject
113
113
Separation Problem
111
111
Leak/Splash
111
111
Material Separation
103
103
Component Missing
98
98
No Display/Image
96
96
Manufacturing, Packaging or Shipping Problem
96
96
Electrical /Electronic Property Problem
86
86
Failure to Cycle
83
83
Material Protrusion/Extrusion
82
82
Structural Problem
77
77
Difficult or Delayed Activation
77
77
Therapeutic or Diagnostic Output Failure
71
71
Overheating of Device
70
70
Use of Device Problem
69
69
Separation Failure
68
68
Premature End-of-Life Indicator
67
67
No Device Output
64
64
Failure to Advance
62
62
Incorrect, Inadequate or Imprecise Result or Readings
61
61
Material Fragmentation
60
60
Battery Problem
58
58
Material Deformation
58
58
Unraveled Material
54
54
Fail-Safe Problem
53
53
Protective Measures Problem
53
53
Excessive Heating
52
52
Device Fell
52
52
Premature Activation
50
50
Device Contamination with Chemical or Other Material
48
48
Display or Visual Feedback Problem
45
45
Loose or Intermittent Connection
44
44
Patient-Device Incompatibility
43
43
Output Problem
43
43
Material Split, Cut or Torn
39
39
Defective Component
37
37
Application Program Version or Upgrade Problem
36
36
Calibration Problem
35
35
Device Remains Activated
34
34
Difficult to Advance
33
33
Packaging Problem
33
33
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
36512
36512
No Consequences Or Impact To Patient
18059
18059
No Code Available
4579
4580
Insufficient Information
4527
4527
Unspecified Tissue Injury
4506
4524
Failure to Anastomose
3533
3533
Hemorrhage/Bleeding
2990
2990
No Known Impact Or Consequence To Patient
2249
2249
Tissue Damage
1343
1343
No Information
1176
1176
Tissue Breakdown
1170
1170
Blood Loss
963
964
No Patient Involvement
921
921
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
515
515
Pain
503
503
Fistula
456
456
Unspecified Infection
349
349
Abscess
313
313
Foreign Body In Patient
276
276
Hematoma
275
275
Laceration(s)
271
271
Abdominal Pain
252
252
Sepsis
249
249
Fever
233
233
Obstruction/Occlusion
218
218
Unintended Radiation Exposure
174
174
Injury
171
171
Death
160
161
Peritonitis
155
155
Hernia
152
152
Inflammation
144
144
Wound Dehiscence
124
124
Vomiting
114
114
Seroma
109
109
Pneumothorax
107
107
Post Operative Wound Infection
103
103
Radiation Exposure, Unintended
99
99
Not Applicable
98
98
Tachycardia
96
96
Nausea
92
92
Pleural Effusion
84
84
Septic Shock
80
80
Adhesion(s)
79
79
Pneumonia
77
77
Low Blood Pressure/ Hypotension
74
74
Bowel Perforation
71
71
Device Embedded In Tissue or Plaque
70
70
Necrosis
68
68
Anemia
66
66
Stenosis
64
64
Abdominal Distention
56
56
Perforation
56
56
Diarrhea
55
55
Impaired Healing
55
55
Pulmonary Emphysema
54
54
Incontinence
53
53
Fluid Discharge
53
53
Urinary Tract Infection
51
51
High Blood Pressure/ Hypertension
44
44
Ulcer
44
44
Ischemia
42
42
Urinary Retention
41
41
Thrombosis/Thrombus
41
41
Cardiac Arrest
40
40
Bacterial Infection
39
39
Renal Failure
37
37
Dyspnea
36
36
Swelling/ Edema
36
36
Purulent Discharge
35
35
Thrombosis
35
35
Pulmonary Embolism
33
33
Ascites
33
33
Discomfort
33
33
Respiratory Failure
31
31
Perforation of Vessels
31
31
Exsanguination
29
29
Distress
29
29
Unspecified Respiratory Problem
29
29
Organ Dehiscence
28
28
Rectal Anastomotic Leakage
28
28
Dehydration
23
23
Failure of Implant
23
23
Myocardial Infarction
22
22
Shock
22
22
Emotional Changes
19
19
Swelling
18
18
Scar Tissue
17
17
Muscle Weakness
16
16
Hypoxia
16
16
Chest Pain
16
16
Dysphagia/ Odynophagia
15
15
Itching Sensation
15
15
Anxiety
15
15
Fibrosis
15
15
Hypersensitivity/Allergic reaction
14
14
Ecchymosis
14
14
Erythema
13
13
Cancer
13
13
Weight Changes
13
13
Syncope/Fainting
13
13
Recalls
Manufacturer
Recall Class
Date Posted
1
COVIDIEN LLC
II
Feb-18-2020
2
Covidien LLC
II
Jun-16-2019
3
Covidien Llc
II
Apr-13-2021
4
Covidien Llc
II
Dec-29-2020
5
Covidien, LP
II
May-24-2024
6
Covidien, LP
II
Apr-01-2024
7
Covidien, LP
II
Mar-06-2023
8
Covidien, LP
II
Apr-09-2021
9
Covidien, LP
II
Oct-01-2020
10
Ethicon Endo-Surgery Inc
II
Jan-26-2024
11
Ethicon Endo-Surgery Inc
II
Aug-19-2021
12
Ethicon Endo-Surgery Inc
I
Oct-29-2019
13
Ethicon Endo-Surgery Inc
I
May-15-2019
14
Ethicon Endo-Surgery Inc
II
Jan-08-2019
-
-