It was reported to aesculap that a crawford intubation set (part # (b)(4) was used during a nasolacrimal duct intubation procedure performed on (b)(6) 2020.According to the complainant, the stylet reportedly detached.Reportedly, the stylet detached from the tubing passing through the canal; by the time the tube was far enough to grasp, the stylet was detached.The surgeon noted that the stylets appear to be further out of the tube when beginning to place.The devices are popping out; no visible damage to tubing was observed, it simply separated.The device was discarded, therefore, it is not available to be returned to the manufacturer for evaluation.Additional information has been requested, but has not yet been made available.
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Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the lot # of the device in question was not known.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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