URETERAL DILATOR 076000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-07-31 for URETERAL DILATOR 076000 manufactured by Cook Inc.

Event Text Entries

[115596593] (b)(6). (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[115596594] A transurethral dilation against the stenosis in the urinary duct was performed. Over a wire guide advanced to the target lesion, dilators contained in the ureteral dilator (076000) were pushed forward. Dilation of the lesion was begun with a thin dilator (8fr), and its diameter was sized up to larger one gradually. When the physician inserted a10fr dilator to the patient's body, resistance was encountered. Resistance was also felt in retrieving the dilator. The physician checked the retrieved dilator, noticing that the tip of it had separated and the separated segment had remained in the urinary duct. A forceps was advanced through a rigid ureteroscope and the separated dilator tip was retrieved out of the patient's body successfully. There were no adverse effects to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-02347
MDR Report Key7736138
Report SourceFOREIGN,HEALTH PROFESSIONAL,O
Date Received2018-07-31
Date of Report2018-09-11
Date of Event2018-07-23
Date Mfgr Received2018-08-13
Device Manufacturer Date2015-10-16
Date Added to Maude2018-07-31
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
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameURETERAL DILATOR
Generic NameKOE DILATOR, URETHRAL
Product CodeKOE
Date Received2018-07-31
Returned To Mfg2018-08-13
Catalog Number076000
Lot Number6292377
Device Expiration Date2018-10-16
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-31

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