GREENLIGHT MOXY FIBER OPTIC 0010-2400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-27 for GREENLIGHT MOXY FIBER OPTIC 0010-2400 manufactured by Boston Scientific Corporation.

Event Text Entries

[185813249] It was reported that after approximately 153,000 joules and 22 minutes at 120w, the fiber stopped firing at 90 degrees and began emitting energy straight out the end of the fiber during a photoselective vaporization of the prostate (pvp) procedure. The procedure was completed utilizing another of the same device. There were no clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2937094-2020-00355
MDR Report Key9891941
Report SourceDISTRIBUTOR
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-02-23
Date Mfgr Received2020-03-19
Device Manufacturer Date2019-08-29
Date Added to Maude2020-03-27
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 ContactALYSON HARRIS
Manufacturer Street150 BAYTECH DRIVE
Manufacturer CitySAN JOSE CA 95134
Manufacturer CountryUS
Manufacturer Postal95134
Manufacturer Phone4089353452
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetPMT 741 PERSIARAN CASSIA SELAT
Manufacturer CityBANDARCASSIA, PULAU PINAN 14110
Manufacturer CountryMY
Manufacturer Postal Code14110
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGREENLIGHT MOXY FIBER OPTIC
Generic NamePOWERED LASER SURGICAL INSTRUMENT
Product CodeGEX
Date Received2020-03-27
Model Number0010-2400
Catalog Number0010-2400
Lot Number0024344980
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressPMT 741 PERSIARAN CASSIA SELAT BANDARCASSIA, PULAU PINAN 14110 MY 14110


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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