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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device suture, absorbable, synthetic, polyglycolic acid
Regulation Description Absorbable poly(glycolide/l-lactide) surgical suture.
Product CodeGAM
Regulation Number 878.4493
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 2
CPT SUTURES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 2
FOOSIN MEDICAL SUPPLIES INC., LTD
  SUBSTANTIALLY EQUIVALENT 2
GORDIAN SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
M/S. MERIL ENDO SURGERY PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NANTONG HOLYCON MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORIGAMI SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ORIGAMI SURGICAL INC .
  SUBSTANTIALLY EQUIVALENT 1
ORIGAMI SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
RESORBA MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
RK MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SILHOUETTE LIFT INC.
  SUBSTANTIALLY EQUIVALENT 1
SILHOUETTE LIFT, INC.
  SUBSTANTIALLY EQUIVALENT 1
SM ENG CO., LTD
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 1498 1498
2018 2228 3465
2019 3564 4679
2020 3414 3414
2021 4505 4871

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5982 8313
Detachment of Device or Device Component 2738 2738
Material Separation 2492 2513
Adverse Event Without Identified Device or Use Problem 1796 2040
Appropriate Term/Code Not Available 584 584
Material Integrity Problem 399 399
Detachment Of Device Component 296 296
Patient-Device Incompatibility 236 236
Unraveled Material 232 232
Material Frayed 184 184
Manufacturing, Packaging or Shipping Problem 164 164
Device Markings/Labelling Problem 122 122
Material Split, Cut or Torn 119 119
Insufficient Information 105 105
Tear, Rip or Hole in Device Packaging 105 105
Product Quality Problem 101 101
Component Missing 100 100
Failure To Adhere Or Bond 100 100
Loss of or Failure to Bond 68 68
Human-Device Interface Problem 68 68
Material Twisted/Bent 65 65
Patient Device Interaction Problem 64 64
Device Operates Differently Than Expected 61 61
Mechanical Problem 57 57
Degraded 49 49
Packaging Problem 47 47
Dull, Blunt 45 45
Component Incompatible 42 42
Device Misassembled During Manufacturing /Shipping 38 38
Component Misassembled 34 34
Material Fragmentation 32 32
Loose or Intermittent Connection 29 29
Device Appears to Trigger Rejection 29 29
Fracture 28 28
Device Slipped 27 27
Bent 26 26
Positioning Failure 25 25
Delivered as Unsterile Product 24 24
Difficult to Open or Remove Packaging Material 23 23
Component or Accessory Incompatibility 20 20
No Apparent Adverse Event 20 20
Use of Device Problem 20 20
Extrusion 19 19
Material Deformation 17 17
Entrapment of Device 17 17
Device Packaging Compromised 14 14
Positioning Problem 13 13
Material Protrusion/Extrusion 12 12
Difficult to Remove 12 12
Material Disintegration 11 11
Device Contamination with Chemical or Other Material 11 11
Material Too Soft/Flexible 11 11
Device Contaminated During Manufacture or Shipping 10 10
Inadequacy of Device Shape and/or Size 10 10
Defective Component 9 9
Defective Device 9 9
Nonstandard Device 9 9
Material Erosion 9 9
Device Fell 9 131
Separation Problem 9 9
Naturally Worn 9 9
Device Issue 8 8
Contamination /Decontamination Problem 7 7
Device Dislodged or Dislocated 7 7
Difficult to Open or Close 7 7
Component Falling 7 7
Migration or Expulsion of Device 7 7
Out-Of-Box Failure 7 7
Device Or Device Fragments Location Unknown 6 6
Failure to Fire 6 6
Malposition of Device 6 6
Difficult To Position 6 6
Migration 6 6
Inaccurate Information 5 5
Compatibility Problem 5 5
Unsealed Device Packaging 5 5
Leak/Splash 4 4
Device Damaged Prior to Use 4 4
Physical Property Issue 4 4
Mechanics Altered 3 3
Incorrect Device Or Component Shipped 3 3
Split 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Puncture/Hole 3 3
Structural Problem 3 3
Material Too Rigid or Stiff 3 3
Knotted 3 3
Contamination 3 3
Cross Reactivity 3 3
Fluid Leak 3 3
Difficult or Delayed Positioning 3 3
Disconnection 2 2
Poor Quality Image 2 2
Misassembled 2 2
Material Rupture 2 2
Expiration Date Error 2 2
Obstruction of Flow 2 2
Missing Information 2 2
Separation Failure 2 2
Failure to Form Staple 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4751 7103
No Clinical Signs, Symptoms or Conditions 3935 4057
No Known Impact Or Consequence To Patient 2211 2211
No Code Available 1030 1030
Wound Dehiscence 917 917
Not Applicable 816 816
Unspecified Infection 666 788
Pain 413 413
Post Operative Wound Infection 395 395
Inflammation 352 352
Insufficient Information 330 330
No Patient Involvement 305 305
Foreign Body In Patient 200 200
Abscess 192 192
Radiation Exposure, Unintended 191 191
Impaired Healing 180 302
No Information 175 175
Blood Loss 173 173
Hematoma 166 166
Hemorrhage/Bleeding 141 263
Seroma 135 135
Swelling 129 129
Erythema 116 116
Unspecified Tissue Injury 114 114
Device Embedded In Tissue or Plaque 109 109
Hernia 97 97
Granuloma 92 92
Unintended Radiation Exposure 88 88
Fistula 84 84
Tissue Damage 82 82
Foreign Body Reaction 79 79
Failure to Anastomose 79 79
Fever 74 74
Purulent Discharge 73 73
Necrosis 71 71
Reaction 66 66
Injury 64 64
Fluid Discharge 62 62
Obstruction/Occlusion 55 55
Cellulitis 55 55
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 53 53
Hypersensitivity/Allergic reaction 52 52
Urinary Tract Infection 52 52
Patient Problem/Medical Problem 44 44
Swelling/ Edema 41 41
Organ Dehiscence 39 39
Irritation 39 39
Incontinence 39 39
Scar Tissue 37 37
Sepsis 35 35
Urinary Retention 33 33
Discomfort 32 32
Local Reaction 31 31
Itching Sensation 28 28
Erosion 28 28
Edema 25 25
Skin Irritation 24 24
Scarring 22 22
Bacterial Infection 22 22
Adhesion(s) 21 21
Rash 21 21
Eye Injury 20 20
Abnormal Vaginal Discharge 17 17
Abdominal Pain 16 16
Skin Erosion 15 15
Pocket Erosion 15 15
Hematuria 14 14
Eye Infections 14 14
Thrombosis 13 13
Blurred Vision 13 13
Death 13 13
Failure of Implant 12 12
Vomiting 12 12
Peritonitis 12 12
Visual Impairment 10 10
Skin Inflammation 10 10
Skin Inflammation/ Irritation 9 9
Discharge 9 9
Cyst(s) 9 9
Anemia 8 8
Laceration(s) 8 8
Stenosis 8 8
Ulcer 8 8
Perforation 8 8
Skin Infection 8 8
Ptosis 8 8
Bowel Perforation 7 7
Cerebrospinal Fluid Leakage 7 7
Dysphagia/ Odynophagia 6 6
Antibiotics, Reaction To 6 6
Bruise/Contusion 6 6
High Blood Pressure/ Hypertension 6 6
Nerve Damage 6 6
Staphylococcus Aureus 6 6
Burning Sensation 6 6
Fibrosis 6 6
Abdominal Distention 5 5
Rupture 5 5
Conjunctivitis 5 5
Diarrhea 4 4

Recalls
Manufacturer Recall Class Date Posted
1 CP Medical Inc II Dec-06-2019
2 CP Medical Inc II Apr-20-2017
3 Covidien LLC II Feb-19-2020
4 Covidien LLC II Aug-03-2018
5 Ethicon, Inc. II Oct-16-2020
6 Ethicon, Inc. II Feb-04-2020
7 Ethicon, Inc. II Apr-12-2019
8 Ethicon, Inc. II Feb-23-2018
9 Gordian Surgical II Nov-03-2020
10 Medtronic II Jun-14-2017
11 Riverpoint Medical, LLC II Feb-03-2021
12 Riverpoint Medical, LLC II Oct-01-2020
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