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On december 13, 2022, misonix llc., a bioventus co., received a product occurrence report on a nexus® standard handpiece, (part number 100-21-0001, serial number (b)(4)) that occurred on (b)(6) 2022, during a cervical laminoplasty.Delay in treatment was not reported.Medical intervention required to preclude serious injury was not reported.Permanent impairment to body structure or body function was not reported.Specifically, it was reported that the "doctor using the microshaver during laminoplasty got burned during usage.Burn to tips of 3 fingers.".Follow-up was conducted with the misonix representative who initiated the report.The degree of the burn was not specified.The representative does not believe any medical treatment was necessary for the burn.The surgeon has not provided any follow up since the incident occurred.
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On december 13, 2022, misonix llc., a bioventus co., received a product occurrence report on a nexus® standard handpiece, (part number 100-21-0001, serial number (b)(4)) that occurred on (b)(6) 2022, during a cervical laminoplasty.Delay in treatment was not reported.Medical intervention required to preclude serious injury was not reported.Permanent impairment to body structure or body function was not reported.Specifically, it was reported that the "doctor using the microshaver during laminoplasty got burned during usage.Burn to tips of 3 fingers." follow-up was conducted with the misonix representative who initiated the report.The degree of the burn was not specified.The representative does not believe any medical treatment was necessary for the burn.The surgeon has not provided any follow up since the incident occurred.The device history record was reviewed for the nexus® standard handpiece, (part number 100-21-0001, serial number (b)(4)).Serial number (b)(4) was manufactured in accordance with the device master record.There were no deviations found during in-process or final inspection of the device.Inspection and test results met specifications prior to release to commerce.The subject handpiece was returned to misonix for evaluation.Inspection and testing confirmed the handpiece operated within specifications.No defects were noted.The handpiece exhibited normal operation and function.No console fault messages were observed.A review of post-market surveillance information for the nexus® standard handpiece did not show any significant adverse trends for user burns.The current frequency of occurrence for user 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 f) 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: 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 attempted follow up with the surgeon; however, misonix has not received any further information.Therefore, further investigation is not possible.Inspection and testing of the returned handpiece concluded the handpiece exhibited normal operation and function.The handpiece met all specifications.A review of post-market surveillance information for the nexus® standard handpiece did not show any significant adverse trends for user 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 f) contains warnings and cautions regarding the surgical technique and device settings required to prevent thermal injury to the user or patient.The investigation has been concluded.
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