Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device mesh, surgical, absorbable, staple line reinforcement
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
2020 4 4
2021 33 33
2022 164 164
2023 26 26
2024 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
Ambient Temperature Problem 152 152
Adverse Event Without Identified Device or Use Problem 59 59
Failure to Form Staple 23 23
Material Integrity Problem 14 14
Mechanical Problem 8 8
Appropriate Term/Code Not Available 5 5
Difficult to Insert 3 3
Failure to Cut 3 3
Failure to Fire 3 3
Difficult to Open or Remove Packaging Material 2 2
Delivered as Unsterile Product 2 2
Firing Problem 2 2
Leak/Splash 1 1
Device Slipped 1 1
Component or Accessory Incompatibility 1 1
Peeled/Delaminated 1 1
Insufficient Information 1 1
Use of Device Problem 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 195 195
Failure to Anastomose 24 24
Hemorrhage/Bleeding 16 16
Adhesion(s) 8 8
Unspecified Infection 7 7
Fever 7 7
Tachycardia 7 7
Pneumothorax 5 5
Pain 5 5
Decreased Appetite 5 5
Nausea 4 4
Fistula 4 4
Pleural Effusion 3 3
Vomiting 3 3
Unspecified Tissue Injury 3 3
Hematoma 2 2
Inflammation 2 2
Seroma 2 2
Insufficient Information 2 2
Abdominal Pain 1 1
Wound Dehiscence 1 1
No Code Available 1 1
Pyrosis/Heartburn 1 1
Obstruction/Occlusion 1 1
Blood Loss 1 1
Chest Pain 1 1
Dyspnea 1 1
Abscess 1 1
Pneumonia 1 1
Fluid Discharge 1 1
Pulmonary Edema 1 1
Shock 1 1
Hypoxia 1 1
Bacterial Infection 1 1
No Consequences Or Impact To Patient 1 1

-
-