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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEW DEANTRONICS LTD VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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NEW DEANTRONICS LTD VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number VL2610DB
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 11/11/2019
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, intra operatively, the patient had a third degree burn on the corner of the lips and in the inner mucosa of the mouth.Patient is currently under the observation of a plastic surgeon.Plastic surgery will be scheduled.They used other brand of generator.
 
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Brand Name
VALLEYLAB
Common Device Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
NEW DEANTRONICS LTD
12f no. 51 sec. 4 chong yang r
taipei 23675
TW  23675
MDR Report Key9387668
Report Number2647580-2019-05827
Device Sequence Number11408019
Product Code GEI
UDI-Device Identifier10884521196681
UDI-Public10884521196681
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K982743
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/27/2019
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 Date02/28/2024
Device Model NumberVL2610DB
Device Catalogue NumberVL2610DB
Device Lot Number1812188X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/11/2019
Initial Report FDA Received Date11/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age18 YR
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