FDA Adverse Event Summary report: N

FORCE FX-C

MDR report key: 1270423 · Received December 22, 2008

Report

Report Number
1270423
Date Received
December 22, 2008
Date of Event
September 15, 2008
Report Date
October 20, 2008
Manufacturer
COVIDIEN VALLEYLAB
Product Code
GEI
Report Source
User Facility report
Reporter Location
MA, US

Narratives

Description of Event or Problem · 1

PATIENT UNDER CONSCIOUS SEDATION FOR INSERTION OF PORTACATH FOR CHEMOTHERAPY INTO RIGHT EXTERNAL JUGULAR VEIN. ESU PENCIL WAS BEING USED TO CONTROL BLEEDING. PATIENT WAS RECEIVING 6L OF OXYGEN VIA FACEMASK AND SURGICAL SITE HAD BEEN PREPPED WITH CHLORAPREP (WHICH CONTAINED 70% ALCOHOL). ANESTHESIOLOGIST SAW 2 SEPARATE FLAMES: ONE BEHIND PATIENT'S RIGHT EAR AND ONE ON RIGHT SIDE OF FACEMASK. ANESTHESIOLOGIST PULLED OFF FACEMASK AND PATTED FLAMES WITH BLUE TOWEL. SCRUB POURED A BOWL OF STERILE SALINE ON PATIENT'S FACE AND SURGEON PULLED ALL DRAPES OFF OF PATIENT. PROCEDURE WAS ABANDONED, PATIENT EXAMINED AND WOUNDS DRESSED. SHE WAS TAKEN INTO RECOVERY AND SEEN BY A BURN SURGEON AND PLASTIC SURGEON. FOUND 2ND DEGREE BURNS AT RIGHT CORNER OF MOUTH, AT THE BASE OF HER RIGHT EAR AND RIGHT SIDE AND BACK OF HER NECK. THEY DID NOT FIND ANY WOUNDS IN NOSE OR MOUTH AND SHE WILL HAVE NO RESPIRATORY CONSEQUENCE. AN OPHTHALMOLOGIST FOUND NO INJURY TO HER EYES.HEALTH PROFESSIONAL'S IMPRESSION:IT IS NOT KNOWN FOR SURE WHAT CAUSED THE ADVERSE EVENT, BUT AFTER DISCUSSION, THE CAUSATION THEORY IS THAT A SPARK OR HEAT FROM THE ESU PENCIL IGNITED THE BLUE COTTON DRAPE THAT MUST HAVE HAD REMNANTS OF THE ALCOHOL-BASED PREP USED TO CLEANSE THE SKIN FOR SURGERY. THE OXYGEN LIKELY POOLED IN HIGH CONCENTRATION AROUND THE FACE MASK AND NEAR THE TABLE AT THE BASE OF THE NECK AND ACTED AS AN ACCELERANT. ADDITIONAL INFORMATION OBTAINED FROM THE SITE: CHLORAPREP WITH TINT, 26ML APPLICATOR, CAT # 260825, LOT #: 23335, EXP: 04/11====================== MANUFACTURER RESPONSE FOR ELECTROSURGICAL UNIT, FORCE FX-C======================SENT QA ANALYST TO TEST DEVICE AT BWH. ALL TESTS PASSED AND SUBMITTED SERVICE REPORT AND FINDINGS TO BIOMED AND RISK MANAGEMENT. SENT ESU PENCIL BACK TO COVIDIEN FOR FURTHER TESTING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FORCE FX-C ELECTROSURGICAL UNIT GEI COVIDIEN VALLEYLAB * *
2 * HANDPIECE, ESU GEI COVIDIEN VALLEYLAB * *

Patients

Seq Age Sex Outcome Treatment
1 * NO OTHER THERAPIES| NO OTHER THERAPIES