• 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 unit, electrosurgical, endoscopic (with or without accessories)
Regulation Description Endoscopic electrosurgical unit and accessories.
Product CodeKNS
Regulation Number 876.4300
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK (CANADA), INC.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS COPR.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 5
SUMITOMO BAKELITE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 757
Failure to Align 487
Adverse Event Without Identified Device or Use Problem 238
Failure to Deliver Energy 186
Material Separation 156
Peeled / Delaminated 98
Probe 86
Wire 84
Positioning Problem 80
Retraction Problem 71
Generator 58
Detachment of Device or device Component 42
Failure to Conduct 37
Migration or Expulsion of Device 36
Use of Device Problem 36
Tip 30
Failure to Cut 28
Electrode 27
Needle 26
Detachment Of Device Component 21
Off-Label Use 21
Device Displays Incorrect Message 19
Device Handling Problem 14
Material Twisted / Bent 14
Device Operates Differently Than Expected 13
Device Dislodged or Dislocated 13
Device Reprocessing Problem 13
Improper or Incorrect Procedure or Method 12
Material Fragmentation 10
Material Frayed 10
Cord 10
Output Problem 10
Material Deformation 9
Material Protrusion / Extrusion 8
Device Contamination with Chemical or Other Material 6
Insufficient Information 6
Failure to Fold 6
Electrical /Electronic Property Problem 6
Difficult to Remove 5
No Device Output 5
Appropriate Term/Code Not Available 5
Catheter 5
Material Integrity Problem 4
Difficult to Advance 4
Tear, Rip or Hole in Device Packaging 4
Fracture 4
Crack 4
Foot Switch 4
Ball 4
Connector 4
Guidewire 3
Bent 3
Energy Output To Patient Tissue Incorrect 3
Malposition of device 3
Mechanical Problem 3
Activation, Positioning or Separation Problem 3
Electrical Shorting 3
Unintended Movement 3
No Apparent Adverse Event 3
Pumping Problem 2
Sharp Edges 2
Material Puncture / Hole 2
Overheating of Device 2
Unsealed Device Packaging 2
Device Damaged Prior to Use 2
Sparking 2
Wire(s), breakage of 2
Defective Component 2
Component Missing 2
Failure to Advance 2
Split 2
Component Falling 2
Material Disintegration 2
Contamination During Use 2
Pump 2
Accessory Incompatible 1
Thermal Decomposition of Device 1
Failure to Capture 1
Circuit Failure 1
Insulation 1
Tip Conductor Coil 1
Seal 1
No Display / Image 1
Component Incompatible 1
Image Orientation Incorrect 1
Loose or Intermittent Connection 1
Arcing 1
Failure to Deliver 1
Component or Accessory Incompatibility 1
Obstruction of Flow 1
Defective Device 1
Arcing of Electrodes 1
Smoking 1
Problem with Sterilization 1
Unexpected Therapeutic Results 1
Device Inoperable 1
Intermittent Energy Output 1
Unclear Information 1
Activation Failure Including Expansion Failures 1
Device Operational Issue 1
Total Device Problems 2920

Recalls
Manufacturer Recall Class Date Posted
1 Akita Sumitomo Bakelite Co., Ltd. II Nov-10-2016
2 NXTHERA II Dec-18-2017
3 Ultroid Technologies, Inc. II Dec-17-2016
4 Wilson-Cook Medical Inc. II Apr-12-2019

-
-