Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Device Code: 1958

Product Code(s): KNS

Device Classification Information

• Device Type ID: 1958
• Device Name: Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
• Regulation Description: Endoscopic Electrosurgical Unit And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Urology And Lithotripsy Devices Branch (ULDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.4300 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KNS
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 6-389 IEC 60601-2-2 Edition 6.0 2017-03
  Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories
• 9-53 ASTM F1992 -99 (Reapproved 2007)
  Standard Practice For Reprocessing Of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used With Flexible Endoscopes

Total Product Life Cycle

• Device Type ID: 1958
• Device: Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
• Product Code: KNS
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Endoscopic Electrosurgical Unit And Accessories.
• CFR Regulation Number: 876.4300 [🔎]

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN LLC
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS COPR.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	3
SUMITOMO BAKELITE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Failure To Align	536
Break	517
Material Separation	158
Failure To Deliver Energy	129
Adverse Event Without Identified Device Or Use Problem	127
Peeled / Delaminated	104
Probe	87
Wire	86
Retraction Problem	74
Positioning Problem	63
Generator	58
Migration Or Expulsion Of Device	39
Failure To Cut	38
Tip	33
Failure To Conduct	33
Detachment Of Device Or Device Component	32
Electrode	29
Use Of Device Problem	26
Needle	26
Detachment Of Device Component	24
Device Displays Incorrect Message	19
Device Operates Differently Than Expected	18
Improper Or Incorrect Procedure Or Method	17
Off-Label Use	14
Device Handling Problem	13
Insufficient Information	13
Device Reprocessing Problem	13
Material Protrusion / Extrusion	11
Output Problem	10
Material Frayed	10
Cord	10
Device Dislodged Or Dislocated	8
Fracture	7
Material Twisted / Bent	6
Appropriate Term/Code Not Available	6
Material Fragmentation	6
Device Contamination With Chemical Or Other Material	6
Catheter	5
Electrical /Electronic Property Problem	5
Sparking	5
Foot Switch	4
Tear, Rip Or Hole In Device Packaging	4
Ball	4
Connector	4
Difficult To Advance	4
Crack	3
No Device Output	3
Electrical Shorting	3
Unintended Movement	3
Guidewire	3
Bent	3
No Apparent Adverse Event	3
Material Puncture / Hole	2
Failure To Fold	2
Energy Output To Patient Tissue Incorrect	2
Insulation	2
Contamination During Use	2
Defective Component	2
Improper Device Output	2
Material Integrity Problem	2
Material Deformation	2
Pump	2
Wire(s), Breakage Of	2
Pumping Problem	2
Overheating Of Device	2
Split	2
Material Distortion	2
Component Falling	2
Device Damaged Prior To Use	2
Malposition Of Device	2
Thermal Decomposition Of Device	1
Entrapment Of Device	1
Image Orientation Incorrect	1
Loose Or Intermittent Connection	1
Sharp Edges	1
Defective Device	1
Difficult To Position	1
Labelling, Instructions For Use Or Training Problem	1
Mechanical Problem	1
Torn Material	1
Unclear Information	1
Component Or Accessory Incompatibility	1
Device Packaging Compromised	1
Component Incompatible	1
Tip Conductor Coil	1
Accessory Incompatible	1
Arcing	1
Failure To Advance	1
Unexpected Therapeutic Results	1
Device Inoperable	1
Material Disintegration	1
Fire	1
Operating System Becomes Nonfunctional	1
Device Operational Issue	1
Infusion Or Flow Problem	1
Difficult To Remove	1
Foot Pedal	1
Circuit Failure	1
Seal	1
Activation, Positioning Or Separation Problem	1
Total Device Problems	2528

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

TPLC Last Update: 2019-04-02 20:02:43