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 forceps, general & plastic surgery
Regulation Description Manual surgical instrument for general use.
Product CodeGEN
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 6 6
2021 20 20
2022 18 18
2023 25 25
2024 20 20
2025 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Break 45 45
Material Fragmentation 11 11
Tear, Rip or Hole in Device Packaging 8 8
Difficult to Open or Close 8 8
Detachment of Device or Device Component 5 5
Mechanical Problem 4 4
Material Integrity Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Fracture 3 3
Improper or Incorrect Procedure or Method 3 3
Device-Device Incompatibility 2 2
Entrapment of Device 2 2
Crack 2 2
Defective Device 2 2
Material Deformation 2 2
Packaging Problem 2 2
Material Separation 2 2
Disconnection 1 1
Leak/Splash 1 1
Output Problem 1 1
Insufficient Information 1 1
Device Fell 1 1
Inadequate Instructions for Healthcare Professional 1 1
Contamination /Decontamination Problem 1 1
Degraded 1 1
Component Missing 1 1
Material Twisted/Bent 1 1
Failure to Cut 1 1
Difficult or Delayed Separation 1 1
Product Quality Problem 1 1
No Apparent Adverse Event 1 1
Device Reprocessing Problem 1 1
Deformation Due to Compressive Stress 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 72 72
Insufficient Information 14 14
Foreign Body In Patient 10 10
Hemorrhage/Bleeding 5 5
No Consequences Or Impact To Patient 4 4
Laceration(s) 3 3
Low Blood Pressure/ Hypotension 3 3
Tooth Fracture 2 2
Pericardial Effusion 2 2
Post Operative Wound Infection 2 2
Device Embedded In Tissue or Plaque 2 2
Unspecified Infection 1 1
No Code Available 1 1
Vascular Dissection 1 1
No Known Impact Or Consequence To Patient 1 1
Injury 1 1
No Patient Involvement 1 1
Perforation of Vessels 1 1
Respiratory Distress Syndrome of Newborns 1 1
Low Oxygen Saturation 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Dec-23-2024
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
3 Sklar Instruments II Jan-16-2025
-
-