GREENLIGHT HPS BPH FIBER OPTIC 0010-2090

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-25 for GREENLIGHT HPS BPH FIBER OPTIC 0010-2090 manufactured by Boston Scientific Corporation.

Event Text Entries

[184912916] It was reported that the fiber tip broke after 30,871 joules and 12:22 minutes of use. The fiber tip was cleaned during the procedure. The fiber was replaced and the procedure completed using a second fiber. The patient outcome was not reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2937094-2020-00334
MDR Report Key9879457
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-03-25
Date of Report2020-03-25
Date of Event2020-01-07
Date Mfgr Received2020-02-28
Device Manufacturer Date2019-04-04
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
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 Street150 BAYTECH DR.
Manufacturer CitySAN JOSE CA 95134
Manufacturer CountryUS
Manufacturer Postal Code95134
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGREENLIGHT HPS BPH FIBER OPTIC
Generic NamePOWERED LASER SURGICAL INSTRUMENT
Product CodeGEX
Date Received2020-03-25
Model Number0010-2090
Catalog Number0010-2090
Lot Number0023594606
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address150 BAYTECH DRIVE SAN JOSE CA 95134 US 95134


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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