MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E2515HGNSB
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a planned closure of mohs defect to nasal tip and upper chest with full thickness skin graft to nose from right pre-auricular area and primary closure of the upper medial check defect under anesthesia monitored intravenous sedation.They initially received the patient with oxygen via nasal cannula, but were unable to maintain the oxygen saturation above 90.They switched to oral cavity and a non-rebreather mask.The hair and beard were clipped and skin prepped with antiseptic scrub.One-half strength antiseptic paint was used on the face and full strength antiseptic paint was used on the chest.More than three minutes lapsed prior to draping.Part of drape placed over bottom portion of the non-rebreather oxygen reservoir over the left chest and shoulder.Bipolar electrocautery was used on the nasal area and the right pre-auricular skin donor site area.When activating a monopolar electrocautery device with a needle tip on the chest defect, there was an arc and flash of fire.Drapes were immediately removed and the area was immediately flushed with saline.The oral airway was removed and inspected and a nasal airway placed.The patient was intubated for airway protection.There was no soot was noted with the intubation.No soot, redness, or swelling was noted in the bronchial tree.There was a 3% partial thickness burn to the lip, neck, shoulder, chest, and back and approximately 1% of that area was a full-thickness burn on the left shoulder.The reminder of the patient's beard and hair which had been significantly singed and caught with the plume was removed.The surgical procedure was completed.Gauze and antibiotic were placed on the left shoulder over the full thickness burn area.Antibiotics were also placed on the face and lips.The patient was awakened and extubated without difficulty.Daily wound care and future plan for skin graft closure to the burn left shoulder.The patient was discharged.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7667690
• Report Number: 1717344-2018-00907
• Device Sequence Number: 11025473
• Product Code: GEI
• UDI-Device Identifier: 10884524003634
• UDI-Public: 10884524003634
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K813071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E2515HGNSB
• Device Catalogue Number: E2515HGNSB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 06/21/2018; 07/26/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 07/11/2018; 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 148