It was reported that during the procedure, the loop retriever was found to be already disassembled between head and shaft and it was noticed when the package was opened.There was no delay or patient injuries but it is unknown how the procedure was finished since no backup device was available to complete it.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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One 7209485 disposable meniscus mender ii set reported on.The complaint stated: ¿it was noticed that there are issues fitting the accupass monofilament down the meniscus mender cannulation.The problem started happening regularly since a few months, as the monofilament stopped working the way it used to.¿ the product was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Engineering evaluation confirmed the product met current specifications at the time of distribution.
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