The device in question was returned to medline renewal for evaluation.Upon receipt, medline renewal confirmed the device had been reprocessed.Further evaluation found that the inner shaft was intact and the shaver was bent but not broken as per the initial report.The reported issue could not be confirmed.Our investigation included a review of the device history record, and we reconfirmed that all processes were conducted as required, and that the device met inspection requirements prior to packaging and release.The specific cause of the bent shaver could not be determined at this time.Per the device's instructions for use (ifu), if a rotating shaver or bur touches another surgical instrument during activation, then device integrity and effectiveness may be compromised.In the event that contact occurs, the user should inspect the tip before proceeding.Additionally, the ifu warns users that increased pressure or side loading of the blade during will not improve the performance of the instrument and that it can dull the blade or cause other damage.The customer confirmed that no adverse patient consequence or additional medical intervention was required as a result of the incident.Even though the device returned for evaluation was intact, medline renewal is filing this medwatch report in an abundance of caution.(b)(4).
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Medline renewal received a report indicating that the tip of the reprocessed linvatec ultracutdual purpose blade, model 35ult-st-zz, detached during a surgical procedure and was retrieved by the surgeon.The customer stated that another device was readily available to complete the procedure, therefore no patient harm or additional medical intervention was reported as a result of the incident.
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