The incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.During the manufacturing process, all seals are thoroughly inspected for functionality and performance prior to packaging.Although the root cause of the experience could not be determined, engineering speculates that the drag force experienced by the customer was most likely caused by non-axial insertion of asymmetrical instruments through the trocar, in addition to multiple instrument exchanges removing applied grease.The instructions for use (ifu) warns that extra care should be used when inserting angular and asymmetrical instruments.All instruments should be centered axially when inserted through the seal.Applied medical continuously seeks to improve the form, function and ease of use of its products and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
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