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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device rongeur, manual
Regulation Description Manual rongeur.
Product CodeHAE
Regulation Number 882.4840
Device Class 2


Premarket Reviews
ManufacturerDecision
ACE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
FEHLING INSTRUMENTS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
K2 MEDICAL GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
MORPHEUS AG
  SUBSTANTIALLY EQUIVALENT 1
RJR SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYMMETRY SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
VITALITEC MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
WIGGINS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 34 34
2017 25 25
2018 30 30
2019 24 24
2020 25 25
2021 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 79 79
Fracture 21 21
Detachment Of Device Component 11 11
Detachment of Device or Device Component 9 9
Dent in Material 7 7
Inadequate Service 7 7
Device Fell 6 6
Maintenance Does Not Comply To Manufacturers Recommendations 5 5
Failure to Cut 5 5
Component Falling 5 5
Bent 5 5
Material Separation 4 4
Material Fragmentation 4 4
Device Operates Differently Than Expected 4 4
Misassembly by Users 4 4
Appropriate Term/Code Not Available 3 3
Device Handling Problem 3 3
Difficult to Advance 3 3
Improper or Incorrect Procedure or Method 3 3
Physical Resistance/Sticking 3 3
Device Dislodged or Dislocated 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Scratched Material 2 2
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Misassembly During Maintenance/Repair 1 1
Device Contamination with Chemical or Other Material 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Difficult to Open or Close 1 1
Device Damaged by Another Device 1 1
Component Missing 1 1
Dull, Blunt 1 1
Device Slipped 1 1
Device Inoperable 1 1
Defective Device 1 1
Device Contamination With Biological Material 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 74 74
No Consequences Or Impact To Patient 29 29
Foreign Body In Patient 10 10
Insufficient Information 9 9
No Clinical Signs, Symptoms or Conditions 8 8
No Information 8 8
No Code Available 4 4
Device Embedded In Tissue or Plaque 3 3
Tissue Damage 2 2
Missing Value Reason 1 1
Failure of Implant 1 1
Nerve Damage 1 1

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