TUR IRRIGATION SET Y-TYPE 06543

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-02-04 for TUR IRRIGATION SET Y-TYPE 06543 manufactured by Hospira De Costa Rica Ltd..

Event Text Entries

[347142] The pt was undergoing surgery for a bladder tumor. The irrigation set was delivering sorbitol via gravity through the surgeon's scope. Reportedly, the tumor was located anterior and "high" in the bladder and the surgeon had to rotate the scope many times. The tubing was reported to disconnect from the scope and the sorbitol solution leaked. The sterile sorbitol solution "sprayed" the surgeon's face. The surgeon was masked and reported to be protected. The set was reconnected to the scope and surgical procedure completed. There was no adverse pt or staff effect.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9615050-2005-00018
MDR Report Key573795
Report Source05
Date Received2005-02-04
Date of Report2005-01-06
Date of Event2004-12-23
Date Mfgr Received2005-01-06
Date Added to Maude2005-02-18
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 Location0
Manufacturer ContactPAUL LANDESMAN, PH.D.,ASST DIR
Manufacturer Street8401 WEST 102ND STREET DEPT.NO.097U, BLDG.NO.HW1 #300
Manufacturer CityPLEASANT PRAIRIE WI 53158
Manufacturer CountryUS
Manufacturer Postal53158
Manufacturer Phone2625776072
Manufacturer G1HOSPITA DE COSTA RICA LTD
Manufacturer StreetZONA FRANCA GLOBAL
Manufacturer CityLA AURORA DE HEREDIA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameTUR IRRIGATION SET Y-TYPE
Generic NameIRRIGATION SET
Product CodeEYZ
Date Received2005-02-04
Model NumberNA
Catalog Number06543
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key563663
ManufacturerHOSPIRA DE COSTA RICA LTD.
Manufacturer AddressZONA FRANCA GLOBAL LA AURORA DE HEREDIA CS
Baseline Brand NameTUR IRRIGATION SET Y-TYPE
Baseline Generic NameIRRIGATION SET
Baseline Model NoNA
Baseline Catalog No06543
Baseline IDNA
Baseline Device FamilySYSTEM, URINE DRAINAGE, CLOSED
Baseline Shelf Life Contained*
Baseline Shelf Life [Months]*
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-02-04

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