MAXENON XI 300 3010 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-23 for MAXENON XI 300 3010 * manufactured by Qed, Inc.

Event Text Entries

[15365027] While performing mastectomy, surgeon used lighted retractor with storz light cord that was attached to light source. A few minutes later, burning smell came from light source and light cord. Tip of light cord where it was plugged in to light source looked burned.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number3788106
MDR Report Key3788106
Date Received2014-04-23
Date of Report2014-04-23
Date of Event2014-04-02
Report Date2014-04-23
Date Reported to FDA2014-04-23
Date Reported to Mfgr2014-05-05
Date Added to Maude2014-05-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameMAXENON XI 300
Generic NameLIGHT, SURGICAL, FIBEROPTIC
Product CodeEQH
Date Received2014-04-23
Model Number3010
Catalog Number*
Lot Number*
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerQED, INC
Manufacturer Address750 ENTERPRISE DR. LEXINGTON KY 40510 US 40510

Device Sequence Number: 2

Brand NameSTORZ BFW ILLUMINATOR
Generic NameILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
Product CodeHBI
Date Received2014-04-23
Model NumberBFW 3010
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Sequence No2
Device Event Key0
ManufacturerBAUSCH & LOMB, INC.
Manufacturer Address1400 NORTH GOODMAN ST ROCHESTER NY 14609 US 14609

Patients

Patient NumberTreatmentOutcomeDate
10 2014-04-23
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