OPEN-END FLEXI-TIP URETERAL CATHETER 021305

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-11-29 for OPEN-END FLEXI-TIP URETERAL CATHETER 021305 manufactured by Cook Inc.

Event Text Entries

[129345439] Pma/510k # pre-amendment. (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


[129345440] The user facility report # mw5080534 was received and the report showed the customer reported, a piece of the open-end flexi-tip ureteral catheter sheared off during case. It is believed that all pieces were removed from the patient. This is now the 3rd device issue with this product. Reference mdr # 1820334-2018-03442 and mdr# 1820334-2018-03444 for the other devices reported to have the same alleged malfunction. No adverse event have been reported as a result of the alleged malfunction. Additional information has been requested regarding the patient and the event. At the time of this report, no further information has been provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-03443
MDR Report Key8115721
Report SourceOTHER
Date Received2018-11-29
Date of Report2018-12-26
Date Mfgr Received2018-12-21
Date Added to Maude2018-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
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 NameOPEN-END FLEXI-TIP URETERAL CATHETER
Generic NameGBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
Product CodeGBL
Date Received2018-11-29
Catalog Number021305
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-29

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