FLEXIVA M0068403920

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for FLEXIVA M0068403920 manufactured by Boston Scientific Corporation.

Event Text Entries

[185722054] Device was noted to be broken prior to procedure, new device obtained and procedure continued without incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9902628
MDR Report Key9902628
Date Received2020-03-31
Date of Report2020-03-12
Date of Event2020-02-10
Report Date2020-03-12
Date Reported to FDA2020-03-12
Date Reported to Mfgr2020-03-31
Date Added to Maude2020-03-31
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEXIVA
Generic NamePOWERED LASER SURGICAL INSTRUMENT
Product CodeGEX
Date Received2020-03-31
Model NumberM0068403920
Catalog NumberM0068403920
Lot Number8111
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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