|
On november 17, 2023, misonix llc., a bioventus co., received a product occurrence report for an event that occurred on november 16, 2023, while using a mis 20mm uni-blade from a nexus® bsa mis decompression kit (blade & shaver) with tubeset (part number 150-32-5501) during a t5, t6, t7 laminectomy and removal of cyst surgical procedure.Specifically, it was reported that while using the bsa blade the surgeon laid the shaft of the probe on the patient's skin causing a burn.The representative confirmed the surgeon acknowledged that the surgical technique used was inconsistent with the instructions in the ifu.Permanent impairment to body structure or body function was not reported.Medical intervention was not reported.Delay in treatment was not reported.
|
|
On november 17, 2023, misonix llc., a bioventus co., received a product occurrence report for an event that occurred on november 16, 2023, while using a mis 20mm uni-blade from a nexus® bsa mis decompression kit (blade & shaver) with tubeset (part number 150-32-5501) during a t5, t6, t7 laminectomy and removal of cyst surgical procedure.Specifically, it was reported that while using the bsa blade the surgeon laid the shaft of the probe on the patient's skin causing a burn.The representative confirmed the surgeon acknowledged that the surgical technique used was inconsistent with the instructions in the ifu.Permanent impairment to body structure or body function was not reported.Medical intervention was not reported.Delay in treatment was not reported.The subject disposable lot number used at the time of the event was not reported and the disposable blade will not be returned for evaluation.Therefore, further evaluation is not possible.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 for the nexus® bsa mis decompression kit (blade & shaver) with tubeset (part number 150-32-5501) did not show any significant adverse trends for thermal injury to the patient or user.The current frequency of occurrence 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 ifu contains a warning that the protective silicone sleeve, included with certain probe tips such as part number 150-32-5501, 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.The investigation has been concluded.The instructions for use manual (100-10-1000, revision j) 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.
|
