FDA Adverse Event Injury Summary report: N

LEX TEX XENON SERIES 9000

MDR report key: 1950573 · Received December 28, 2010

Report

Report Number
MW5018753
Event Type
Injury
Date Received
December 28, 2010
Date of Event
December 1, 2010
Report Date
December 28, 2010
Manufacturer
LEX TEX CORP
Product Code
GCT
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

NOT A DEVICE ERROR- CLINICIAN ERROR: (B)(6) 2010, A MEDIASTINOSCOPE WAS USED FOR OBTAINING BIOPSIES. AFTER THIS PART OF THE PROCEDURE, THE SURGICAL FIELD WAS BROKEN DOWN AND PREPARED FOR THE SECOND PART OF THE PROCEDURE. DURING THIS TRANSITION, THE MEDIASTINOSCOPE WAS SEPARATED FROM THE LIGHT CORD. THE LIGHT CORD WAS PLACED ON THE MAYO STAND ON ONE SIDE OF THE SURGICAL FIELD AND WAS STILL "ON" AND CONNECTED TO THE LIGHT SOURCE WHICH WAS ON THE OPPOSITE SIDE OF THE SURGICAL FIELD. THE LIGHT CORD TIP IS HOT WHEN ILLUMINATED. THE CORD MAY HAVE EXTENDED ACROSS THE PT OR AROUND THE HEAD OF THE BED BASED ON STAFF RECALL OF THE EVENT. IT IS BELIEVED THAT AT THE SAME TIME, THE DRAPES WERE REMOVED, EQUIPMENT REPOSITIONED AND THE PT'S BED REPOSITIONED TO ACCOMMODATE THE NEXT PART OF THE SURGERY, THE LIGHT CORD, LOCATED ON THE MAYO STAND, WAS TUGGED THEN POSSIBLY DRAGGED ACROSS THE PT, THUS THE END OF THE CORD COMING IN CONTACT WITH THE PT'S SKIN. IT WAS THEN NOTED THAT THE PT HAD SUSTAINED A "NICKEL" SIZED BURN TO THE LEFT CLAVICULAR AREA. THE SURGICAL TEAM DID NOT WITNESS THE ACTUAL EVENT, HOWEVER, THE TEAM DETERMINED THE BURN MUST HAVE OCCURRED FROM THE LIGHT CORD DURING THE TRANSITION OF THE SECOND PROCEDURE. ON (B)(6) 2010, PT DISCHARGED WITH 2CM DIAMETER WOUND, GIVEN TREATMENT INSTRUCTIONS. ON (B)(6) 2010, SURGEON CALLED TO INFORM FACILITY, WOUND NOT HEALING AND PT WOULD NEED REFERRAL TO PLASTIC SURGEON. WOUND APPROX A QUARTER IN SIZE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LEX TEX XENON SERIES 9000 LEX TEC LIGHT SOURCE AND CORD 9300 GCT LEX TEX CORP

Patients

Seq Age Sex Outcome Treatment
1 69 YR Other