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On (b)(6), 2023, misonix® llc., a bioventus® co., received a product occurrence report on a nexus® bonescalpel® macro hook shaver + irrigation tubing kit, (part number 110-31-1220) that occurred on (b)(6), 2023, during a lumbar spinal procedure while using a nexus® standard handpiece (part number 100-21-0001).Specifically, the report indicated the handpiece heated up and burnt the resident surgeon's hand and the patient's skin.The degree of the burn to the resident or the patient was not specified.Permanent impairment to body structure or body function was not reported.Medical intervention was required by the surgeon to ellipse the skin to remove the burn and close the incision.Delay in treatment was not reported.Misonix has not received any further information at the time of this report.Misonix is actively working with the representative who submitted the initial report for full case details.The subject handpiece serial number and the disposable probe tip lot number used at the time of the event were not reported.It has not yet been specified if the devices used at the time of the event will be returned for evaluation.Therefore, further evaluation is not possible at this time.A review of post-market surveillance information for the nexus® standard handpiece and the nexus® bonescalpel® macro hook shaver + irrigation tubing kit, (part number 110-31-1220) did not show any significant adverse trends for user or patient burns.The current frequency of occurrence for user or patient burns is within the frequency originally estimated in the original risk management report.Therefore, there is no change to the residual risk or risk-benefit ratio.The instructions for use manual (100-10-1000, revision g) 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: 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.Misonix has not received any further information at the time of this report.Misonix is actively working with the representative who submitted the initial report for full case details.It has not yet been specified if the devices used at the time of the event will be returned for evaluation.A follow up report will be submitted once the investigation is completed.A review of post-market surveillance information for the nexus® standard handpiece and the nexus® bonescalpel® macro hook shaver + irrigation tubing kit, (part number 110-31-1220) did not show any significant adverse trends for user or patient burns.The current frequency of occurrence for user burns is within the frequency originally estimated in the original risk management report.The instructions for use manual (100-10-1000, revision g) contains warnings and cautions regarding the surgical technique and device settings required to prevent thermal injury to the user or patient.
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On (b)(6), 2023, misonix® llc., a bioventus® co., received a product occurrence report on a nexus® bonescalpel® macro hook shaver + irrigation tubing kit, (part number 110-31-1220) that occurred on (b)(6), 2023, during a lumbar spinal procedure while using a nexus® standard handpiece (part number 100-21-0001).Specifically, the report indicated the handpiece heated up and burnt the resident surgeon's hand and the patient's skin.The degree of the burn to the resident or the patient was not specified.Permanent impairment to body structure or body function was not reported.Medical intervention was required by the surgeon to ellipse the skin to remove the burn and close the incision.Delay in treatment was not reported.Misonix has not received any further information at the time of this report.Misonix is actively working with the representative who submitted the initial report for full case details.
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