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

Model Number	VL2610
Medical Device Problem Codes	Failure to Deliver Energy (1211); Flare or Flash (2942)
Health Effect - Clinical Codes	Burn(s) (1757); Blood Loss (2597)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
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 device¿s coagulating function did not work with popping when triggered.As a result, device induced a small burn on the breasts and bleeding.

• 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: 7266895
• Report Number: 1717344-2018-00210
• Device Sequence Number: 13866966
• Product Code: GEI
• UDI-Device Identifier: 20884521196633
• UDI-Public: 20884521196633
• 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: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 1702028X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1