ELECTO-SURGICAL UNIT
Received Jul 23, 1993
Report 10031 · MDR key 10031
Device
Manufacturer
Valley LabModel number
FORCE 2-20, PC 21287Patient
UNK
Narrative
Description of Event or Problem
FOLLOWING SMOOTH HALOTHAN INDUCTION, PATIENT UNDERWENT MYRINGTOMY TUBE PLACEMENT UNDER MASK ANESTHESIA. THIS WAS FOLLOWED BY INTUBATION IN PREPARATION FOR TONISLLECTOMY. SURGEON PACKED THROAT. AFTER INITIATION OF ELECTROCAUTERY AN AIRWAY FIRE ENSUED. AN EVACUATION OF THE FIRE WAS PERFORMED IMMEDIATELY. PATIENT VITAL SIGNS WERE STABLE FOLLOWING INCIDENT. EVALUATION OF THE INCIDENT & EQUIP. WAS PERFORMED BY ECRI WITH ALL EQUIP FOUND TO BE WORKING PROPERLY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.