Dislodger, Stone, Basket, Ureteral, Metal

Device Code: 1806

Product Code(s): FFL

Device Classification Information

• Device Type ID: 1806
• Device Name: Dislodger, Stone, Basket, Ureteral, Metal
• Regulation Description: Ureteral Stone Dislodger.
• 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) Exempt
• CFR Regulation Number: 876.4680 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FFL
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-405 IEC 80601-2-59 Edition 2.0 2017-09
  Medical Electrical Equipment - Part 2-59: Particular Requirements For The Basic Safety And Essential Performance Of Screening Thermographs For Human Febrile Temperature Screening
• 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: 1806
• Device: Dislodger, Stone, Basket, Ureteral, Metal
• Product Code: FFL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Ureteral Stone Dislodger.
• CFR Regulation Number: 876.4680 [🔎]

Device Problems
Difficult To Open Or Close	321
Break	317
Wire	108
Device Operates Differently Than Expected	105
Material Separation	75
Extractor	59
Detachment Of Device Or Device Component	41
Device Damaged Prior To Use	30
Difficult Or Delayed Positioning	23
Detachment Of Device Component	18
Mechanical Problem	12
Material Twisted / Bent	12
Difficult To Remove	11
Device Operational Issue	10
Kinked	10
Fracture	9
Device Contamination With Chemical Or Other Material	8
Material Deformation	7
Bent	7
Device Inoperable	7
Improper Or Incorrect Procedure Or Method	7
Tear, Rip Or Hole In Device Packaging	7
Device Packaging Compromised	6
Mechanical Jam	5
Off-Label Use	5
Unintended Collision	5
Torn Material	5
Adverse Event Without Identified Device Or Use Problem	5
Seal	5
Physical Resistance / Sticking	4
Material Fragmentation	4
Unsealed Device Packaging	3
Retraction Problem	3
Structural Problem	3
Tip	3
Appropriate Term/Code Not Available	2
Use Of Device Problem	2
Component Missing	2
Device Contaminated During Manufacture Or Shipping	2
Defective Device	2
Component(s), Broken	2
Loose Or Intermittent Connection	2
Material Rupture	2
Entrapment Of Device	2
Flaked	1
Crack	1
Collapse	1
Stretched	1
Split	1
Naturally Worn	1
Packaging Problem	1
Insufficient Information	1
Positioning Failure	1
Wire(s), Breakage Of	1
Screw	1
Degraded	1
Deformation Due To Compressive Stress	1
Activation, Positioning Or Separation Problem	1
Device Dislodged Or Dislocated	1
Coiled	1
Material Integrity Problem	1
Product Quality Problem	1
Total Device Problems	1296

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard, Inc.	II	Oct-31-2014

TPLC Last Update: 2019-04-02 19:59:55