• 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 motor, surgical instrument, ac-powered
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGEY
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2020 952 952
2021 1145 1145
2022 1360 1360
2023 1444 1444
2024 1449 1449
2025 422 422

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 2673 2673
Complete Loss of Power 1752 1752
Excessive Heating 954 954
Appropriate Term/Code Not Available 548 548
Unintended System Motion 525 525
Mechanical Jam 493 493
Detachment of Device or Device Component 387 387
Intermittent Loss of Power 360 360
Noise, Audible 353 353
Device Alarm System 345 345
Material Fragmentation 326 326
Device-Device Incompatibility 231 231
Vibration 224 224
Output below Specifications 219 219
Break 207 207
Leak/Splash 169 169
Fail-Safe Did Not Operate 152 152
Device Slipped 113 113
Material Frayed 107 107
Fail-Safe Problem 75 75
Premature Separation 63 63
Fracture 61 61
Mechanical Problem 45 45
Difficult or Delayed Separation 41 41
Device Reprocessing Problem 39 39
Overheating of Device 36 36
Intermittent Energy Output 30 30
Electrical /Electronic Property Problem 21 21
Component Missing 21 21
Adverse Event Without Identified Device or Use Problem 20 20
Environmental Particulates 19 19
Packaging Problem 18 18
Circuit Failure 16 16
Energy Output Problem 13 13
Fluid/Blood Leak 12 12
Separation Failure 12 12
Corroded 11 11
Device Contaminated During Manufacture or Shipping 9 9
Unintended Movement 8 8
Improper or Incorrect Procedure or Method 8 8
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Separation Problem 7 7
Fire 6 6
Suction Failure 6 6
Connection Problem 6 6
Positioning Failure 4 4
Difficult to Open or Close 4 4
Contamination /Decontamination Problem 4 4
Failure to Cut 3 3
Device Markings/Labelling Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5912 5912
No Consequences Or Impact To Patient 799 799
No Known Impact Or Consequence To Patient 23 23
Osteolysis 7 7
Unspecified Tissue Injury 7 7
Bone Fracture(s) 6 6
Insufficient Information 6 6
Injury 5 5
Burn(s) 5 5
Embolism/Embolus 4 4
Limb Fracture 4 4
Foreign Body In Patient 3 3
Unspecified Infection 2 2
Post Operative Wound Infection 1 1
Headache 1 1
Blood Loss 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Not Applicable 1 1
No Code Available 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Tinnitus 1 1
Unspecified Musculoskeletal problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Pro-Dex Inc II Jul-05-2023
-
-