MAUDE Adverse Event Report: CONMED CORPORATION SUREFIT GROUNDING PAD WITH 10' CABLE

Catalog Number	410-2000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 410-2000 surefit¿ dispersive electrodes is listed as available for evaluation on the maude report, but no contact information is listed for user facility.To date, no devices have been returned to the conmed quality assurance laboratory for evaluation regarding a complaint of "a small burn at the edge of the pad on the patient's right lateral thigh." no visual evidence (photographs) of failure have been made available.An evaluation of the complaint device could not be completed therefore the reported failure cannot be verified; the complaint is unconfirmed.A review of the manufacturing documents from the dhr/lhr has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.A review of the complaint history for this lot of product and event description shows there have been no other similar complaints received.A two (2) year review of product history for this device family showed there have been a total of four (4) similar occurrences of "burned", including this complaint, all of which have been unconfirmed.During the same two (2) year timeframe, over (b)(4) units were sold world-wide, making this occurrence rate for this reported failure mode (b)(4) percent.As no failure analysis could be performed on this device, no manufacturing defects have been identified.No further action is planned at this time.The reported complaint issue will continue to be monitored through the complaint system.Causes of patient burns involving dispersive electrodes are typically associated with concentration of current density.This phenomenon is created by peeling or tenting of the pad, insufficient contact due to insufficient skin preparation (hair, lotions, oil, etc.).In these cases automatic return monitoring circuitry would alarm if any of these situations exists with a dual channel electrode such as the 410-2000 device.The electrosurgical generator in use at the time of the incident is unknown.To reduce the risk of patient injury, the instructions for use (ifu) states: "avoid placement on bony prominence, skin lesions or folds, tattoos, scars, metal prosthesis or near ecg electrodes and cables.Do not apply where fluid may pool." the ifu further warns: "failure to achieve good skin contact by the entire adhesive surface of the dispersive electrode may result in electrosurgical burns or poor electrosurgical perfomance." "difficulty in achieving cutting or coagulating energies requires evaluation.Stop.Do not proceed or increase power setting until you have checked all components of the electrosurgical circuit including the active electrode and its cable, the patient, dispersive electrode adherence and integrity and the electrical generator and its connectors.Indiscriminate power increase may result in patient burns." h3 other text : no user contact info on maude.
Event or Problem Description
As reported on maude adverse event report number (b)(4): "a (b)(6) male admitted for an elective neurosurgical procedure on (b)(6) 2016.At the start of the procedure, the neurosurgeon noted the bovie was not delivering the desired power.The procedure was stopped as the circulating rn traced the electrosurgical equipment from pen to generator and noted "green" light present indicating good grounding and can proceed.Then continued tracing to pt at bovie pad.The bovie pad was removed which revealed a small burn at the edge of the pad on the pt's right lateral thigh.The neurosurgeon decided to abort the case due to the burn.A general surgeon assessed the site and excised the burned tissue.This resulted in a 2cm x 6 cm incision wound that was closed with nylon sutures and dressing applied.Sutures to be removed by general surgeon in one week.Original neurosurgical procedure to be rescheduled in 2-3 weeks." no contact information for reporter or user facility is listed on maude report and therefore, to date, there has been no additional information received regarding the patient's latest condition or any indication of long term adverse effect has occurred.

• Brand Name: SUREFIT GROUNDING PAD WITH 10' CABLE
• Common Device Name: GROUNDING PAD
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6266723
• Report Number: 3007305485-2017-00013
• Device Sequence Number: 16224047
• Product Code: GEI
• UDI-Device Identifier: 00653405033830
• UDI-Public: (01)00653405033830
• Combination Product (Y/N): N
• PMA/510(K) Number: K120322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/20/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2017
• Device Catalogue Number: 410-2000
• Device Lot Number: 201506265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 01/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention