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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, absorbable, staple line reinforcement
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
Product CodeOXC
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 2
GUNZE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 33 33
2022 164 164
2023 26 26
2024 38 38
2025 45 45
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Ambient Temperature Problem 173 173
Adverse Event Without Identified Device or Use Problem 72 72
Failure to Form Staple 24 24
Material Integrity Problem 21 21
Mechanical Problem 9 9
Appropriate Term/Code Not Available 8 8
Failure to Fire 5 5
Difficult to Insert 3 3
Failure to Cut 3 3
Delivered as Unsterile Product 3 3
Difficult to Open or Remove Packaging Material 2 2
Patient Device Interaction Problem 2 2
Device Appears to Trigger Rejection 2 2
Firing Problem 2 2
Leak/Splash 1 1
Component or Accessory Incompatibility 1 1
Peeled/Delaminated 1 1
Insufficient Information 1 1
Contamination /Decontamination Problem 1 1
Use of Device Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Mechanical Jam 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 229 229
Failure to Anastomose 28 28
Hemorrhage/Bleeding 23 23
Adhesion(s) 10 10
Unspecified Infection 8 8
Fever 7 7
Tachycardia 7 7
Fistula 6 6
Pneumothorax 5 5
Pain 5 5
Unspecified Tissue Injury 5 5
Decreased Appetite 5 5
Inflammation 3 3
Pleural Effusion 3 3
Vomiting 3 3
Insufficient Information 3 3
Wound Dehiscence 2 2
Nausea 2 2
Fungal Infection 2 2
Hematoma 2 2
Obstruction/Occlusion 2 2
Rash 2 2
Seroma 2 2
Scar Tissue 2 2
Shock 2 2
Abdominal Pain 1 1
Hypersensitivity/Allergic reaction 1 1
Sepsis 1 1
Pyrosis/Heartburn 1 1
Cardiac Arrest 1 1
Chest Pain 1 1
Dyspnea 1 1
Abscess 1 1
Pneumonia 1 1
Fluid Discharge 1 1
Anaphylactic Shock 1 1
Pulmonary Edema 1 1
Hypoxia 1 1
Bacterial Infection 1 1

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