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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
Product CodeGAM
Regulation Number 878.4493
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC
  SUBSTANTIALLY EQUIVALENT 1
ETHICON, INC.
  SUBSTANTIALLY EQUIVALENT 3
FOOSIN MEDICAL SUPPLIES INC., LTD
  SUBSTANTIALLY EQUIVALENT 2
ORIGAMI SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ORIGAMI SURGICAL INC .
  SUBSTANTIALLY EQUIVALENT 2
ORIGAMI SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
RESORBA MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
RK MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SAMYANG HOLDINGS CORP., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SILHOUETTE LIFT INC.
  SUBSTANTIALLY EQUIVALENT 1
SM ENG CO., LTD
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 2228 3465
2019 3564 4679
2020 3414 3414
2021 4504 4870
2022 4813 5545
2023 3954 3954

Device Problems MDRs with this Device Problem Events in those MDRs
Break 8702 11277
Material Separation 4769 4790
Detachment of Device or Device Component 4121 4121
Adverse Event Without Identified Device or Use Problem 2790 3278
Material Integrity Problem 593 593
Material Frayed 346 346
Appropriate Term/Code Not Available 328 328
Patient-Device Incompatibility 321 321
Material Split, Cut or Torn 256 256
Unraveled Material 247 247
Manufacturing, Packaging or Shipping Problem 217 339
Device Markings/Labelling Problem 210 210
Insufficient Information 156 156
Component Missing 146 146
Material Twisted/Bent 112 112
Tear, Rip or Hole in Device Packaging 109 109
Product Quality Problem 109 109
Patient Device Interaction Problem 108 108
Detachment Of Device Component 105 105
Component Misassembled 98 98
Dull, Blunt 86 86
Human-Device Interface Problem 82 82
Positioning Failure 69 69
Loss of or Failure to Bond 68 68
Mechanical Problem 67 67
Packaging Problem 63 63
Difficult to Open or Remove Packaging Material 62 62
Delivered as Unsterile Product 58 58
Defective Component 52 52
Device Operates Differently Than Expected 45 45
Use of Device Problem 42 42
Device Slipped 41 41
Device Appears to Trigger Rejection 40 40
Component or Accessory Incompatibility 35 35
Device Contaminated During Manufacture or Shipping 35 35
Component Incompatible 33 33
Fracture 32 32
Material Fragmentation 29 29
Loose or Intermittent Connection 26 148
Difficult to Remove 24 24
Degraded 24 24
Material Deformation 22 22
Device Misassembled During Manufacturing /Shipping 20 20
Entrapment of Device 19 19
Extrusion 18 18
Material Protrusion/Extrusion 14 14
Failure To Adhere Or Bond 14 14
Nonstandard Device 13 13
Positioning Problem 13 13
Device Contamination with Chemical or Other Material 11 11
Device Packaging Compromised 11 11
Material Too Soft/Flexible 11 11
Defective Device 11 11
Material Disintegration 11 11
Inadequacy of Device Shape and/or Size 10 10
Device Fell 10 254
Separation Problem 9 9
Difficult to Open or Close 9 9
No Apparent Adverse Event 9 9
Bent 9 9
Material Erosion 9 9
Material Discolored 9 9
Device Issue 8 8
Biocompatibility 8 8
Contamination /Decontamination Problem 7 7
Mechanics Altered 7 7
Migration 6 6
Failure to Fire 6 6
Malposition of Device 6 6
Separation Failure 5 5
Leak/Splash 5 5
Unsealed Device Packaging 5 5
Inaccurate Information 5 5
Compatibility Problem 5 5
Device Dislodged or Dislocated 5 5
Therapeutic or Diagnostic Output Failure 4 4
Physical Property Issue 4 4
Missing Information 4 4
Sharp Edges 3 3
Disconnection 3 3
Fluid/Blood Leak 3 3
Difficult or Delayed Positioning 3 3
Cross Reactivity 3 3
Contamination 3 3
Device Damaged Prior to Use 3 3
Structural Problem 3 3
Material Too Rigid or Stiff 3 3
Material Puncture/Hole 3 3
Improper or Incorrect Procedure or Method 2 2
Material Rupture 2 2
Obstruction of Flow 2 2
Out-Of-Box Failure 2 2
Failure to Form Staple 2 2
Expiration Date Error 2 2
Migration or Expulsion of Device 2 2
Misassembled 2 2
Physical Resistance/Sticking 2 2
Expulsion 2 2
Difficult to Advance 2 2
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10551 10795
No Consequences Or Impact To Patient 4546 6898
No Known Impact Or Consequence To Patient 1478 1478
Wound Dehiscence 1244 1244
Insufficient Information 1014 1014
Unspecified Infection 807 929
No Code Available 791 791
Not Applicable 752 752
Pain 513 635
Post Operative Wound Infection 494 616
Inflammation 480 480
Foreign Body In Patient 359 481
Impaired Healing 308 430
No Patient Involvement 292 292
Hemorrhage/Bleeding 283 527
Unspecified Tissue Injury 280 280
Unintended Radiation Exposure 228 228
Abscess 220 220
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 217 217
Hematoma 207 207
Seroma 168 168
No Information 167 167
Erythema 162 162
Blood Loss 153 153
Fluid Discharge 144 144
Hernia 135 135
Failure to Anastomose 133 377
Radiation Exposure, Unintended 133 133
Necrosis 128 128
Pocket Erosion 118 118
Granuloma 113 113
Swelling 111 111
Purulent Discharge 110 110
Swelling/ Edema 108 108
Fistula 101 101
Foreign Body Reaction 98 98
Obstruction/Occlusion 95 95
Fever 93 93
Scar Tissue 89 89
Device Embedded In Tissue or Plaque 89 89
Hypersensitivity/Allergic reaction 87 87
Cellulitis 66 66
Skin Inflammation/ Irritation 66 66
Urinary Tract Infection 64 64
Tissue Damage 63 63
Discomfort 63 63
Reaction 56 56
Incontinence 54 54
Local Reaction 47 47
Injury 40 40
Patient Problem/Medical Problem 39 39
Sepsis 39 39
Irritation 38 38
Urinary Retention 37 37
Bacterial Infection 36 36
Erosion 34 34
Itching Sensation 32 32
Eye Injury 31 31
Adhesion(s) 29 29
Abdominal Pain 25 25
Edema 24 24
Organ Dehiscence 24 24
Laceration(s) 21 21
Abnormal Vaginal Discharge 21 21
Scarring 20 20
Rash 19 19
Peritonitis 19 19
Skin Irritation 18 18
Stenosis 17 17
Skin Erosion 16 16
Ulcer 15 15
Hematuria 15 15
Eye Infections 15 15
Vomiting 14 14
Blurred Vision 13 13
Blister 13 13
Skin Infection 12 12
Tissue Breakdown 12 12
Failure of Implant 12 12
Death 11 11
Perforation 11 11
Nerve Damage 11 11
Visual Impairment 10 10
Thrombosis 10 10
Chills 10 10
Cyst(s) 10 10
Cerebrospinal Fluid Leakage 10 10
Anxiety 10 10
Ptosis 9 9
Anemia 9 9
Visual Disturbances 8 8
Fibrosis 8 8
Skin Inflammation 8 8
Bowel Perforation 7 7
Shock 7 7
Septic Shock 6 6
Staphylococcus Aureus 6 6
Burning Sensation 6 6
Diarrhea 6 6
Dysphagia/ Odynophagia 6 6

Recalls
Manufacturer Recall Class Date Posted
1 CP Medical Inc II Dec-06-2019
2 Covidien LLC II Feb-19-2020
3 Covidien LLC II Aug-03-2018
4 Covidien, LP II Nov-11-2022
5 Ethicon, Inc. II Oct-31-2022
6 Ethicon, Inc. II May-10-2022
7 Ethicon, Inc. II Oct-16-2020
8 Ethicon, Inc. II Feb-04-2020
9 Ethicon, Inc. II Apr-12-2019
10 Ethicon, Inc. II Feb-23-2018
11 Gordian Surgical II Nov-03-2020
12 Riverpoint Medical, LLC II Feb-03-2021
13 Riverpoint Medical, LLC II Oct-01-2020
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