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On august 30, 2023, misonix llc., a bioventus co., received a report of an event that occurred during a facial feminization procedure and a gonial angle reduction.Specifically, the misonix representative indicated "the chief oral surgery resident was using the 20 mm lcrs attachment.During the procedure the surgeon was required to make gonial angle cuts.The attending used the device on his side without any damage.When the resident went to make the cuts on his side, the exposed metal contacted the underlying lip for a brief period of time.After this occurred, it was noted there was a burn to the soft tissue." medical intervention was required to treat the burn which included ointment and an intraoperative second opinion provided by plastic surgery.Additional surgery was performed the following day to excise the dead tissue caused by the thermal injury.
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On august 30, 2023, misonix llc., a bioventus co., received a report of an event that occurred during a facial feminization procedure and a gonial angle reduction.Specifically, the misonix representative indicated "the chief oral surgery resident was using the 20 mm lcrs attachment.During the procedure the surgeon was required to make gonial angle cuts.The attending used the device on his side without any damage.When the resident went to make the cuts on his side, the exposed metal contacted the underlying lip for a brief period of time.After this occurred, it was noted there was a burn to the soft tissue." medical intervention was required to treat the burn which included ointment and an intraoperative second opinion provided by plastic surgery.Additional surgery was performed the following day to excise the dead tissue caused by the thermal injury.Additional details of the procedure were provided by the misonix representative present for the event: ent opened the case using a nexus® standard handpiece (part number 100-21-0001, serial number (b)(6)) with two separate nexus® probe tips.One probe tip was a nexus® diamond shaver, part number 110-31-1230, which includes an irrigation tubing kit.The lot number was not reported.The item number and lot number of the other probe tip was not reported.The second half of the surgery was completed by the chief oral surgery resident and the attending surgeon.A bonescalpel® 20mm, long curved rigid blunt blade (part number mxb-mis-20lcrs, lot number 81685) was assembled to the nexus® standard handpiece using the remaining nexus® tubing kit from the previous surgical procedure.The thermal injury occurred while using the bonescalpel® 20mm, long curved rigid blunt blade (part number mxb-mis-20lcrs, lot number 81685) due to improper surgical technique.The resident surgeon did not keep the exposed metal off of the soft tissue as he was using the device - this is inconsistent with the surgical technique in the instructions for use manual ((b)(4)) for the nexus® ultrasonic surgical aspiration system and can cause thermal injury, tissue necrosis, and burns.The procedure was completed using a nexus® 25mm, blunt blade + irrigation tubing kit (part number 110-31-1125).The patient underwent surgery the following day to excise the dead tissue that occurred as a result of the thermal injury.Follow up confirms the patient is recovering well.The hospital performed an investigation into the event and found the root cause to be user error.Proper surgical technique was discussed and the misonix representative confirmed the hospital is satisfied with the product and have continued to use the nexus® system.The subject handpiece and disposables used at the time of the event will not be returned to misonix for evaluation.The lot numbers for the nexus® diamond shaver, part number 110-31-1230 and the nexus® 25mm, blunt blade + irrigation tubing kit (part number 110-31-1125) were not reported; therefore, a device history review cannot be performed.The device history record for the bonescalpel® 20mm, long curved rigid blunt blade (part number mxb-mis-20lcrs, lot number 81685) and the nexus® standard handpiece, (part number 100-21-0001, serial number (b)(6)) were reviewed.The review indicated that these devices were manufactured in accordance with the device master record.There were no deviations found during in-process or final inspection.Inspection and test results met specifications prior to release to commerce.Due to the nature in which ultrasonic devices transfer energy into the target tissue, thermal events may occur.A review of post-market surveillance information did not show any significant adverse trends for thermal injury to the patient or user.The investigation has been concluded.The instructions for use manual ((b)(4)) for the nexus® ultrasonic surgical aspiration system contains the following warnings and cautions regarding the surgical technique and device settings required to prevent thermal injury to the patient or user: warning the nexus® ultrasonic surgical aspirator system is intended to be used in various types of invasive, surgical procedures.There may be indirect danger to the patient should the device fail during the procedure.It is recommended that the facility follows its back-up equipment protocols.Caution the system check should always be done in advance of preparing patient for surgery to minimize risk to patient in case of system malfunction.Caution it is strongly advised that a sterile backup handpiece be readily available in the operating room as insurance any contamination or malfunction of the handpiece used during surgery.Potential burn hazard.Warning nexus® probes have a silicone or hard plastic sheath.Compressing or bending the sheath may cause the sheath to contact the vibrating surface along the length of the probe or at the probe tip and may cause excessive heating, which may burn user or patient tissue at the surgical site.Warning excessive loading of nexus® probes at the surgical site may induce heating due to vibration and friction as target tissue is fragmented and emulsified.It is critical to manage the temperature of the probe by adjusting the irrigation, aspiration, and ultrasound settings, and surgical technique.Tissue necrosis may result if probe tip is not moved relative to tissue.A continuous, lateral sweeping motion is recommended in order to minimize contact duration with the ultrasonic probe tip and minimize heat build-up.When lateral motion is not possible withdraw and re-insert probe tip frequently.Warning contact to vibrating elements like an extension and ultrasonic probe tip may cause burns and should be avoided by all means.The handpiece should only be held at the black handpiece housing area and/or the black hard sheath.Warning a protective silicone sleeve, included with certain probe tips, reduces the risk of thermal damage but does not eliminate it.Contact with the silicone sleeve should be avoided or kept brief with minimal amount of contact pressure.Pressure and extended exposure can still result in excessive frictional heat and cause burns.Warning contact of the rigid or silicone sheaths with patient tissue under pressure, may create a burn hazard.Avoid contact of sheath elements with patient tissue under pressure.Warning probe tip temperatures may exceed the tissue necrosis point if insufficient irrigant is present at the probe tip-tissue interface.For hard tissue removal, always use the maximum irrigation flowrate that does not affect the surgical field of view, or impact surgical technique.Additional external irrigation, e.G., by administering sterile saline with a syringe over the distal probe tip portion, may be necessary for removal of very dense, hard osseous structures.Warning hard tissue applications, a minimum irrigation setting of 20 is recommended to minimize or prevent thermal injury and/or tissue necrosis.Caution insufficient irrigation and high tip pressure (loading) under extended exposure, e.G., in tight cavities, are to be avoided while removing hard tissue.It is recommended to withdraw and re-insert the ultrasonic tips (e.G., blades & shavers) repeatedly to re-establish adequate cooling and lubrication.Caution additional external irrigation, e.G., by administering sterile saline with a syringe over the distal tip portion, may be necessary when removing very dense, hard osseous structures.Caution prime the irrigation tubing prior to use.At all times ensure that the irrigation flows towards the handpiece when footswitch is depressed.If no irrigation is flowing, cease use until flow is restored.
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