MAUDE Adverse Event Report: NEW DEANTRONICS LTD VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VL2610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient suffered from 3rd degree burn on the face around the nose.Upon testing of the devices, it was seen that the generator had current leakage under the following settings: "ative", function pure cut - 329ma "ative", function coag - 196ma dispersive, function pure cut - 250ma dispersive, function coag - 63ma.Also the pencil was arcing and sparking.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient suffered from 3rd degree burn on the face around the nose.Upon testing of the devices, it was seen that the generator had current leakage under the following settings: ative, function pure cut - 329ma ative, function coag - 196ma dispersive, function pure cut - 250ma dispersive, function coag - 63ma.Also the pencil was arcing and sparking and there was a fire present but extinguished by cloth.The analysis of the picture provided shows that the nasal cannula was burnt.
Additional Manufacturer Narrative
Evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.The product was not included in the pictures provided.The picture showed burns on a patient.The reported condition was not confirmed because the actual device was not received.Without the product, a detailed investigation could not be performed.The file will be closed as unconfirmed at this time.If additional information is obtained, or the product is returned, we will re-open this investigation.The investigation could not determine the root cause of the customer's report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient suffered from 3rd degree burn on the face around the nose.Upon testing of the devices, it was seen that the generator had current leakage under the following settings : ative, function pure cut - 329ma ative, function coag - 196ma dispersive, function pure cut - 250ma dispersive, function coag - 63ma.Also the pencil was arcing and sparking and there was a fire present but extinguished by cloth.The analysis of the picture provided shows that the nasal cannula was burnt.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NEW DEANTRONICS LTD; 12f. no.51.sec. 4 chong yang; tu cheng district 23675 ; TW 23675
• MDR Report Key: 8116809
• Report Number: 1717344-2018-01560
• Device Sequence Number: 16519251
• Product Code: GEI
• UDI-Device Identifier: 10884521196636
• UDI-Public: 10884521196636
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K982743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2019

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 Expiration Date: 04/30/2022
• Device Model Number: VL2610
• Device Catalogue Number: VL2610
• Device Lot Number: 1702031X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 01/29/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/07/2019; 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention