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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, surgical, orthopedic, dc-powered motor and accessory/attachment
Product CodeKIJ
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
INSURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 36 36
2015 36 36
2016 11 11
2017 1 1
2018 1 1
2019 1 1
2020 1 1
2022 4 4
2023 6 6
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Disassembly 19 19
Unintended Power Up 16 16
Device-Device Incompatibility 10 10
Battery Problem 9 9
Overheating of Device 9 9
Smoking 8 8
Unintended Movement 7 7
Fluid/Blood Leak 7 7
Leak/Splash 6 6
Break 5 5
Component Missing 3 3
Device Operates Differently Than Expected 3 3
Delayed Charge Time 3 3
Failure to Shut Off 2 2
Device Dislodged or Dislocated 2 2
Metal Shedding Debris 2 2
Bent 1 1
Unintended System Motion 1 1
Device Inoperable 1 1
Unintended Ejection 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Fracture 1 1
Corroded 1 1
Entrapment of Device 1 1
Insufficient Information 1 1
Device Fell 1 1
Failure to Clean Adequately 1 1
Failure to Fire 1 1
Component Falling 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 53 53
No Known Impact Or Consequence To Patient 17 17
No Clinical Signs, Symptoms or Conditions 12 12
No Information 7 7
No Consequences Or Impact To Patient 4 4
Foreign Body In Patient 2 2
Insufficient Information 2 2
Therapeutic Effects, Unexpected 2 2
Burn, Thermal 1 1
Pain 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Instruments Div. of Stryker Corporation II Mar-10-2009
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