ELECTROSURGICAL * E2610-6

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-03-26 for ELECTROSURGICAL * E2610-6 manufactured by Covidien.

Event Text Entries

[1064575] 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======================
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1352006
MDR Report Key1352006
Date Received2009-03-26
Date of Report2009-03-26
Date of Event2009-03-05
Report Date2009-03-26
Date Reported to FDA2009-03-26
Date Added to Maude2009-03-30
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 NameELECTROSURGICAL
Generic NameHANDSWITCHING SUCTION COAGULATOR
Product CodeGEI
Date Received2009-03-26
Model Number*
Catalog NumberE2610-6
Lot Number151616
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address5920 LONGBOW DRIVE BOULDER CO 80301 US 80301

Device Sequence Number: 2

Brand NameINFANT REM POLYHESIVE II
Generic NameELECTRODE DISPERSIVE, ESU
Product CodeODR
Date Received2009-03-26
Model Number154649
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Sequence No2
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address5920 LONGBOW DRIVE BOULDER CO 80301 US 80301

Device Sequence Number: 3

Brand NameKENDALL DOVER ROB-NEL
Generic NameCATHETER; 12 FRENCH; LATEX-FREE
Product CodeKOD
Date Received2009-03-26
Model Number492003
Catalog Number*
Lot Number824886764
ID Number*
Device AvailabilityY
Device Sequence No3
Device Event Key0
ManufacturerCOVIDIEN KENDALL
Manufacturer Address15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048

Device Sequence Number: 4

Brand NameMALLINCKRODT UNCUFFED TRACHEAL TUBE 4.0 MM
Generic NameENDOTRACHEAL TUBE
Product CodeBTR
Date Received2009-03-26
Model Number*
Catalog Number86225
Lot Number081200 1216
ID Number*
Device AvailabilityN
Device Sequence No4
Device Event Key0
ManufacturerCOVIDIEN MALLINCKRODT
Manufacturer Address675 MCDONNELL BLVD. MAIL STOP ST. LOUIS, MO 63134 US 63134

Device Sequence Number: 5

Brand NameHIBICLENS
Generic NameANTISEPTIC/ANTIMICROBIAL SKIN CLEANSER
Product CodeLOP
Date Received2009-03-26
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Device Sequence No5
Device Event Key0
ManufacturerMOLNLYCKE HEALTH CARE US
Manufacturer Address5550 PEACHTREE PARKWAY SUITE 5 NORCROSS GA 30092 US 30092


Patients

Patient NumberTreatmentOutcomeDate
10 2009-03-26

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