MAUDE Adverse Event Report: HALYARD HEALTH HALYARD* CURVED SHARP RF CANNULA, RADIOPAQUE MARKER; STANDARD RF PROBES AND CANNULAS

Model Number	12480
Medical Device Problem Codes	Smoking (1585); Sparking (2595)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 18-may-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported the "needle near the skin of the patient smoked and sparked" during use of the pain generator.The clinicians were performing a 3-level lumbar, single probe case.As soon as the smoking and sparking started the clinicians stopped the use of the pain generator.When restarted, it happened again, and the impedance was high.The device was restarted once more and the procedure was completed without incident.The clinicians performed a cervical case later and had no issue nor a repeat of the incident.The clinicians noticed the impedance was high and reached up to ohms (shut off the generator occurs at 1000 ohms).Additional information received 02-may-2018 stated after removing the cannulas they noticed one of the cannulas was missing about 2mm of black insulation from the active tip.The physician commented that it looked charred.No patient injury observed.
Additional Manufacturer Narrative
The device history record for the reported lot number, m18003k502, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 01-aug-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Common Device Name: STANDARD RF PROBES AND CANNULAS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7545324
• Report Number: 8030647-2018-00294
• Device Sequence Number: 1262056
• Product Code: GXI
• UDI-Device Identifier: 30680651124808
• UDI-Public: 30680651124808
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2018

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: Nurse
• Device Expiration Date: 01/18/2018
• Device Model Number: 12480
• Device Catalogue Number: 991012480
• Device Lot Number: M18003K502
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 08/02/2018
• Patient Sequence Number: 1