The device was not returned to stryker sustainability solutions for evaluation.It was stated the device was disposed of by the customer facility.As the device was not returned for evaluation, visual and functional inspection was unable to be performed.A review of the dhr could not be performed as the lot number and/or serial number was not reported.The reported event could be attributed to the user applying too much force to the device or the arthroscopic shaver may have come into contact with staples, clips or another metal object, resulting in damage to the blade.The instructions for use (ifu) state: - before beginning the procedure, verify compatibility of all instruments and accessories.- plug in and set up the generator according to the instructions in the manufacturers¿ manual.- select an arthroscopic shaver with size, blade, and function most appropriate for the procedure.- inspect the instrument for overall condition and physical integrity.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.- careful handling of the instrument is necessary to avoid damage or breakage as a result of excessive force.- do not apply excessive pressure or ¿side-load¿ the blade during use.Side-loading does not improve the performance of the instrument, can dull the blade, and/or produce metal particulates.- do not allow the arthroscopic shaver to come into contact with staples, clips or any metal object to avoid damage to the blade and possible patient injury.- the tip of the bur or cutter must be irrigated periodically (general recommendation: once a minute) to cool the blade and prevent excised tissues from accumulating.- do not run the instrument without appropriate suction for the duration of the process.Should the device become available for return, the investigation will be reopened at that time.The reported event will continue to be monitored through post-market surveillance.(b)(4).
|
It was reported the doctor was using the arthroscopic shaver on the patient and everything was fine.A post-op x-ray was taken and it was noticed there were pieces of the device that had been left in the patient.Multiple attempts were made to obtain additional information, including patient status.No information was provided.However, there was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
|