MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. RADIOFREQUENCY NITINOL PROBE; RADIOFREQUENCY PROBE

Model Number PMP-145C-N

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

The sample has been returned and is being evaluated.If any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a follow-up report.Information from this incident will be included in our product complaint and mdr trend reporting systems.Ongoing analysis of trend information is used to identify the need for additional investigations.

Event Description

A report was received for an incident which occurred during a standard radiofrequency procedure of the left knee.During the procedure, an error appeared on the generator stating the temperature was out of range.The temperature was set at 90 degrees, but began to climb to 99 degrees.Once the temperature reached 99 degrees, the generator shut off.However, the impedance functioned during this time.There were three different radiofrequency needles used on different nerves of the knee.A skin burn occurred.The physician is unsure which needle was involved.The device was replaced and the procedure was completed without incident.The patient is currently stable and doing fine.Please note that halyard health owns this product line, and have reported an mdr for this incident under manufacturer report number: 3011270181-2015-00021.

• Brand Name: RADIOFREQUENCY NITINOL PROBE
• Type of Device: RADIOFREQUENCY PROBE
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, quebec H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 2645 matheson blvd. east; mississauga, ontario L4W 5 S4; CA L4W 5S4
• Manufacturer Contact: meghal khakhar ; 2645 matheson blvd. east; mississauga, ontario L4W 5-S4 ; CA L4W 5S4 ; 90560
• MDR Report Key: 5086357
• MDR Text Key: 26111608
• Report Number: 9710452-2015-00007
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: PMP-145C-N
• Device Catalogue Number: PMP-145C-N
• Device Lot Number: PNFB230712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 75