FDA Adverse Event Summary report: N

ELECTROSURGICAL

MDR report key: 1352006 · Received March 26, 2009

Report

Report Number
1352006
Date Received
March 26, 2009
Date of Event
March 5, 2009
Report Date
March 26, 2009
Manufacturer
COVIDIEN
Product Code
GEI
Report Source
User Facility report
Reporter Location
OH, US

Narratives

Description of Event or Problem · 1

AT THE START OF ADENOIDECTOMY SURGERY, A TONGUE BLADE AND MOUTHGAG WERE INSERTED AND THE MOUTH WAS OPENED FOR EXPOSURE. A RED NON-LATEX ROBINSON CATHETER WAS PLACED TRANSNASALLY AND BROUGHT OUT TRANSORALLY TO HELP ELEVATE THE PALATE FOR EXPOSURE OF THE NASOPHARYNX AND ACCESS TO THE NASOPHARYNX FOR ADENOIDECTOMY. AT THE START OF ADENOIDECTOMY BY THE TECH METHOD OF FULGURATION USING SUCTION CAUTERY, AN APPARENT OXYGEN LEAK RESULTED IN A SPARK WITH IGNITED RED NON-LATEX ROBINSON CATHETER WHICH RAPIDLY BEGAN TO SMOULDER. A FIRE ESTIMATED TO BE THE SIZE OF A FIFTY CENT PIECE WAS OBSERVED IN THE ORAL CAVITY. THE ENDOTRACHEAL TUBE AND THE RED ROBINSON WERE IMMEDIATELY REMOVED FROM THE PATIENT AND THE ORAL CAVITY DOUSED WITH SALINE AND SUCTIONED OUT . THE PATIENT WAS RE-INTUBATED WITH AN ENDOTRACHEAL TUBE. IMMEDIATE EXAMINATION OF THE ORAL CAVITY AND LARYNX REVEALED THAT THE PATIENT HAD A 0.5 CM X 2 CM BURN ON THE LEFT LATERAL TONGUE AS WELL AS AN 8 MM X 8 MM BURN ON THE BUCCAL MUCOSA OF THE RIGHT LATERAL LOWER LIP JUST INFERIOR TO THE CREASE OF THE ORAL COMMISSURE. THE AREA WAS IMMEDIATELY ICED. THE BURNS CONTINUED TO BE ICED; DESPITE NO EVIDENCE OF BURN ON THE ENDOTRACHEAL TUBE, IT WAS REMOVED FROM THE PATIENT. THE DECISIONWAS MADE TO CONFIRM THAT THERE WAS NO AIRWAY INJURY AND DIRECT LARYNGOSCOPY AND BRONCHOSCOPY WAS PERFORMED WITH CONFIRMATION OF NO AIRWAY INJURY TO THE LARYNX OR TRACHEA TO THE LEVEL OF THE CARINA.HEAELTH PROFESSIONAL IMPRESION:UNCUFFED ETT WITH A LARGE AIR LEAK THAT INCREASED WHEN NECK HYPEREXTENDED; 02 FLOW RATE HIGH AT 89%-92% AT TIME OF EVENT; NO SOAKED GAUZE THROAT PACKS IN PLACE; RED NON-LATEX ROBINSON CATHETER IN MOUTH; DILUTED HIBICLENS BEING USED AS A DENTAL MIRROR DEFOGGING AGENT; SUCTION CAUTERY SPARK. ADDITIONAL INFORMATION RECEIVED FROM THE SITE: BURN CLASSED AS SUPERFICIAL AND MINOR BY THE PHYSICIAN BURN SPECIALIST; TREATED WITH NEOSPORIN. BIOMED TESTED THE UNIT WAS OPERATING TO ALL STANDARDS. HIBICLENS WAS USED AS DILUTED SOLUTION TO DEFOG THE DENTAL MIRROR NOT AS A SURGICAL SCRUB.====================== MANUFACTURER RESPONSE FOR INFANT REM POLYHESIVE II, VALLEYLAB============================================ MANUFACTURER RESPONSE FOR ELECTROSURGICAL GENERATOR; HANDSWITCHING SUCTION COAGULATOR, VALLEYLAB======================THE MANUFACTURER HAS CONTACTED US AND HAS OFFERED THAT THE DEVICE BE RETURNED FOR INVESTIGATION AT THEIR LABORATORY. THEY HAVE ALSO OFFERED TO SEND US INFORMATION AND A TRAINING DVD ON OR FIRE PREVENTION. ALL EQUIPMENT INCLUDING THE COVIDIEN ELECTROSURGICAL GENERATOR PASSED ALL EQUIPMENT TESTING. AT THIS TIME, WE ARE NOT PLANNING TO RETURN THE GENERATOR TO COVIDIEN.====================== MANUFACTURER RESPONSE FOR CATHETER; 12 FRENCH; LATEX-FREE, KENDALL DOVER ROB-NEL======================

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ELECTROSURGICAL HANDSWITCHING SUCTION COAGULATOR GEI COVIDIEN * 151616
2 INFANT REM POLYHESIVE II ELECTRODE DISPERSIVE, ESU ODR COVIDIEN 154649 *
3 KENDALL DOVER ROB-NEL CATHETER; 12 FRENCH; LATEX-FREE KOD COVIDIEN KENDALL 492003 824886764
4 MALLINCKRODT UNCUFFED TRACHEAL TUBE 4.0 MM ENDOTRACHEAL TUBE BTR COVIDIEN MALLINCKRODT * 081200 1216
5 HIBICLENS ANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER LOP MOLNLYCKE HEALTH CARE US * *

Patients

Seq Age Sex Outcome Treatment
1 1 YR