FLEXOR URETERAL ACCESS SHEATH AND DILATORS FUS-120045

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-08 for FLEXOR URETERAL ACCESS SHEATH AND DILATORS FUS-120045 manufactured by Cook Inc.

Event Text Entries

[91323105] (b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[91323106] The area representative reported that a male patient underwent a ureteroscopy and laser lithotripsy, and basket extraction of kidney stones. During the procedure, the flexor ureteral access sheath and dilators were utilized. As reported, a shred of plastic from a 45cm ureteric access sheath was noted in the patient? S ureter during the surgery and it was retrieved. No unintended portion of any of these devices was left in the patient? S body. There were no additional procedures required due to the reported issues. There has been no adverse effect to the patient resulting of the reported device issues.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2017-03915
MDR Report Key7009188
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-11-08
Date of Report2018-02-15
Date of Event2017-10-27
Date Mfgr Received2018-01-25
Date Added to Maude2017-11-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXOR URETERAL ACCESS SHEATH AND DILATORS
Generic NameKOE DILATOR, URETHRAL
Product CodeKOE
Date Received2017-11-08
Catalog NumberFUS-120045
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-11-08

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