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TPLC
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Device
clip, implantable
Product Code
FZP
Regulation Number
878.4300
Device Class
2
Premarket Reviews
Manufacturer
Decision
A2 MEDICAL SYSTEMS, LLC
SUBSTANTIALLY EQUIVALENT
2
AESCULAP INC.
SUBSTANTIALLY EQUIVALENT
1
DANNIK
SUBSTANTIALLY EQUIVALENT
1
ETHICON ENDO SURGERY, LLC.
SUBSTANTIALLY EQUIVALENT
1
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
SUBSTANTIALLY EQUIVALENT
1
NEURAMEDICA INC
SUBSTANTIALLY EQUIVALENT
1
TAIWAN SURGICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
TELEFLEX MEDICAL
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2019
2903
2955
2020
1760
1760
2021
1759
1759
2022
1575
1575
2023
1915
1915
2024
386
386
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanics Altered
2228
2228
Failure to Form Staple
1937
1989
Mechanical Problem
1280
1280
Difficult to Open or Close
1006
1006
Failure to Fire
945
945
Break
833
833
Detachment of Device or Device Component
461
461
Mechanical Jam
455
455
Positioning Failure
435
435
Activation, Positioning or Separation Problem
414
414
Material Deformation
236
236
Misfire
203
203
Device Slipped
201
201
Adverse Event Without Identified Device or Use Problem
185
185
Firing Problem
165
165
Device Fell
138
138
Failure to Advance
127
127
Insufficient Information
125
125
Failure to Align
113
113
Fail-Safe Problem
109
109
Entrapment of Device
85
85
Display or Visual Feedback Problem
80
80
No Apparent Adverse Event
75
75
Unintended Ejection
71
71
Noise, Audible
64
64
Physical Resistance/Sticking
54
54
Material Fragmentation
51
51
Loss of or Failure to Bond
50
50
Patient Device Interaction Problem
48
48
Appropriate Term/Code Not Available
47
47
Material Integrity Problem
40
40
Defective Device
34
34
Difficult to Remove
33
33
Material Twisted/Bent
31
31
Component Missing
30
30
Delivered as Unsterile Product
30
30
Migration
29
29
Use of Device Problem
28
28
Tear, Rip or Hole in Device Packaging
27
27
Product Quality Problem
26
26
Activation Failure
24
24
Device Dislodged or Dislocated
23
23
Leak/Splash
23
23
Positioning Problem
22
22
Fracture
21
21
Difficult or Delayed Positioning
20
20
Defective Component
19
19
Premature Activation
18
18
Difficult to Insert
18
18
Therapeutic or Diagnostic Output Failure
16
16
Ejection Problem
15
15
Activation Problem
15
15
Patient-Device Incompatibility
13
13
Material Separation
13
13
Unsealed Device Packaging
12
12
Unintended Movement
12
12
Manufacturing, Packaging or Shipping Problem
11
11
Loose or Intermittent Connection
11
11
Component or Accessory Incompatibility
11
11
Expiration Date Error
11
11
Improper or Incorrect Procedure or Method
10
10
Output Problem
10
10
Device Markings/Labelling Problem
10
10
Failure to Eject
10
10
Device Damaged by Another Device
9
9
Material Protrusion/Extrusion
9
9
Compatibility Problem
9
9
Separation Problem
8
8
Image Display Error/Artifact
8
8
Premature Separation
7
7
Packaging Problem
7
7
Shipping Damage or Problem
6
6
Material Puncture/Hole
5
5
No Device Output
5
5
Difficult to Advance
5
5
Material Split, Cut or Torn
5
5
Device Contamination with Chemical or Other Material
4
4
Precipitate in Device or Device Ingredient
4
4
Migration or Expulsion of Device
4
4
Crack
4
4
Deformation Due to Compressive Stress
4
4
Contamination /Decontamination Problem
3
3
Separation Failure
3
3
Retraction Problem
3
3
Fluid/Blood Leak
3
3
Device Handling Problem
3
3
Overcorrection
2
2
Lack of Effect
2
2
Difficult or Delayed Separation
2
2
Corroded
2
2
Material Too Rigid or Stiff
2
2
Material Rupture
2
2
Device Damaged Prior to Use
2
2
Difficult or Delayed Activation
2
2
Incomplete Coaptation
2
2
Device Displays Incorrect Message
2
2
Malposition of Device
2
2
Connection Problem
1
1
Failure to Cut
1
1
Inadequacy of Device Shape and/or Size
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5238
5238
No Consequences Or Impact To Patient
3680
3732
Insufficient Information
478
478
No Known Impact Or Consequence To Patient
296
296
Hemorrhage/Bleeding
183
183
No Information
160
160
No Code Available
127
127
No Patient Involvement
110
110
Unspecified Tissue Injury
106
106
Failure to Anastomose
58
58
Tissue Damage
49
49
Blood Loss
49
49
Foreign Body In Patient
47
47
Pain
40
40
Tissue Breakdown
28
28
Perforation of Vessels
22
22
Hematoma
21
21
Laceration(s)
18
18
Injury
18
18
Inflammation
16
16
Unspecified Infection
14
14
Hypersensitivity/Allergic reaction
14
14
Perforation
13
13
Device Embedded In Tissue or Plaque
12
12
Not Applicable
10
10
Patient Problem/Medical Problem
10
10
Abscess
10
10
Unintended Radiation Exposure
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
10
10
Death
9
9
Fistula
9
9
Abdominal Distention
9
9
Fluid Discharge
8
8
Failure of Implant
8
8
Abdominal Pain
8
8
Anemia
8
8
Sepsis
8
8
Wound Dehiscence
7
7
Post Operative Wound Infection
7
7
Rash
6
6
Thrombus
5
5
Nerve Damage
5
5
Hemostasis
5
5
Fatigue
5
5
Obstruction/Occlusion
5
5
Vomiting
5
5
Peritonitis
5
5
Discomfort
4
4
Unspecified Kidney or Urinary Problem
4
4
Thrombosis/Thrombus
4
4
Radiation Exposure, Unintended
4
4
Low Blood Pressure/ Hypotension
4
4
Nausea
3
3
Itching Sensation
3
3
Fever
3
3
Foreign Body Reaction
3
3
Exsanguination
3
3
Headache
3
3
Cardiac Arrest
3
3
Dyspnea
3
3
Unspecified Heart Problem
3
3
Renal Impairment
3
3
Intra-Abdominal Hemorrhage
3
3
Arthralgia
3
3
Hematuria
3
3
Diaphoresis
3
3
Weight Changes
2
2
Depression
2
2
Hernia
2
2
Stenosis
2
2
Burning Sensation
2
2
Urinary Tract Infection
2
2
Dizziness
2
2
Skin Inflammation/ Irritation
2
2
Cough
2
2
Constipation
2
2
Dysphagia/ Odynophagia
2
2
Dehydration
2
2
Hair Loss
2
2
Emotional Changes
2
2
Erythema
2
2
Scar Tissue
2
2
Necrosis
2
2
Neuropathy
2
2
Occlusion
1
1
Pleural Effusion
1
1
Pneumonia
1
1
Loss of Range of Motion
1
1
Irritation
1
1
Left Ventricular Dysfunction
1
1
Liver Laceration(s)
1
1
Memory Loss/Impairment
1
1
Menstrual Irregularities
1
1
Muscle Weakness
1
1
Tinnitus
1
1
Vitreous Hemorrhage
1
1
Transient Ischemic Attack
1
1
Urinary Retention
1
1
Renal Failure
1
1
Right Ventricular Dysfunction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Sep-27-2021
2
Ethicon Endo-Surgery Inc
II
Dec-06-2019
3
Genicon, Inc.
II
Oct-30-2020
4
TELEFLEX LLC
II
May-30-2023
5
Teleflex Medical
II
Nov-19-2019
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