FDA Adverse Event Injury Summary report: N

CONMED CORPORATION

MDR report key: 364165 · Received November 15, 2001

Report

Report Number
364165
Event Type
Injury
Date Received
November 15, 2001
Date of Event
October 9, 2001
Report Date
October 23, 2001
Manufacturer
CONMED ELECTRO SURGERY
Product Code
GEI
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

A PT WAS SCHEDULED FOR A BILATERAL MYRINGOTOMY WITH PE TUBES (BMT) AND AN ADENIDECTOMY. THE BMT WAS COMPLETED WITHOUT COMPLICATION. DURING THE PROCEDURE TO REMOVE THE ADENOID TISSUE, THERE WAS A FIRE IN THE ORAL CAVITY POSSIBLY SPARKED BY THE USE OF THE ELECTROCAUTERY DEVICE. MD TOOK IMMEDIATE ACTION TO EXTINGUISH THE FIRE. THE ORAL CAVITY WAS EXTENSIVELY IRRIGATED WITH NORMAL SALINE, AND DR THOROUGHLY EXAMINED THE TISSUES TO EVALUATE THE EXTENT OF THE INJURY. DR DETERMINED THAT THE PT WOULD LIKELY EXPERIENCE SOME EDEMA, AND SHOULD BE TRANSFERRED TO HOSPITAL FOR OBSERVATION AND EXTENSIVE EVALUATION OF THE ORAL AND PHARYNGEAL CAVITIES. DR CALLED AN ENT SPECIALIST INTO THE OPERATING ROOM TO EXAMINE THE PT AND TRANSFER THE PT'S CARE WHILE THE PT IS HOSPITALIZED. DR MADE TRANSFER ARRANGEMENTS WITH THE EMERGENCY TRANSFER TEAM AND THE PT REMAINED STABLE AND SEDATED IN THE OPERATING ROOM UNTIL THE TRANSFER TEAM ARRIVED. THE TEAM OF PHYSICIANS AND NURSES RECEIVED REPORT ON THE PT, AND PT WAS DISCHARGED IN THEIR CARE, VIA AMBULANCE. THEY HAVE CONTINUED TO MAINTAIN CONTACT WITH HOSPITAL, AND HAVE STAYED ABREAST OF THE PT'S STATUS. THE PT HAD A BRONCHOSCOPY AND THE NURSES AT THE HOSPITAL REPORTED THAT THE PT HAS SUPERFICIAL BURNS IN THE BACK OF THE PT'S THROAT, AND NO OTHER APPARENT DAMAGE. DR IS AWAITING A DISCHARGE SUMMARY FROM THE FACILITY. THE PT WAS DISCHARGED FIVE DAYS LATER AND IS AT HOME RECUPERATING WITH PT'S FAMILY MEMBERS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
51787 CONMED CORPORATION ELECTROSURGICAL UNIT GEI CONMED ELECTRO SURGERY 60-5800-001 NA

Patients

Seq Age Sex Outcome Treatment
1 4 YR Hospitalization