GREENLIGHT XPS LASER SYSTEM 0010-0210R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-25 for GREENLIGHT XPS LASER SYSTEM 0010-0210R manufactured by Boston Scientific Corporation.

Event Text Entries

[186610772] It was reported that during preparation for a photoselective vaporization of the prostate procedure the console did not start at the time to prepare the last procedure. The patient was present and sedated but the procedure could not be completed due to this event. There were no complications to the patient. This event its being reported for aborted/cancelled procedure with a patient under anesthesia.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2937094-2020-00344
MDR Report Key9880448
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Device Manufacturer Date2012-09-27
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactALYSON HARRIS
Manufacturer Street150 BAYTECH DRIVE
Manufacturer CitySAN JOSE CA 95134
Manufacturer CountryUS
Manufacturer Postal95134
Manufacturer Phone4089353452
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street2 RUE RENE CAUDRON
Manufacturer CityVOISINS-LE-BRETONNEUX 78960
Manufacturer CountryFR
Manufacturer Postal Code78960
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGREENLIGHT XPS LASER SYSTEM
Generic NamePOWERED LASER SURGICAL INSTRUMENT
Product CodeGEX
Date Received2020-03-25
Model Number0010-0210R
Catalog Number0010-0210R
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address2 RUE RENE CAUDRON VOISINS-LE-BRETONNEUX 78960 FR 78960


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-25

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