MAUDE Adverse Event Report: US SURGICAL PUERTO RICO VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VL2610DB
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	12/07/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, intra-operatively, the patient received a first degree burn on the breast nipple.A megadyne electrode was in use as well.It was unknown how was the burn treated.
Additional Manufacturer Narrative
Correction: 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 received a first degree burn on the breast nipple.A megadyne electrode was in use as well.The pencil was placed in the holster when not in use and the generator was in standard 40 mode and settings.The burn was found during the surgery and there were no pictures of the burn.It was unknown how was the burn was treated.
Additional Manufacturer Narrative
Evaluation summary: one vl2610db was received for evaluation.This device had been used in the treatment or diagnosis of a patient.Without the original packaging or a reported lot number, the investigator cannot determine if the product was within the assigned expiration date at the time of reported incident.The returned product met specification as received.Visual inspection found no defects.The customer reported a device related burn.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.Visual inspection found no damage to the device.The device was plugged into a 40k ohm test box and activated in both the cut and coag mode with satisfactory results.The device plugged into a generator and activated normally.The plug, cord, and body of the device were hipot (high potential) tested with satisfactory results indicating no electrical leakage.The investigation found the device to function normally and within specifications.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): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7143691
• Report Number: 2647580-2017-09163
• Device Sequence Number: 19118872
• Product Code: GEI
• UDI-Device Identifier: 20884521196688
• UDI-Public: 20884521196688
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K982743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2018

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: 01/02/2022
• Device Model Number: VL2610DB
• Device Catalogue Number: VL2610DB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 02/22/2018; 02/22/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 03/14/2018; 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1