(b)(4).The actual device was returned by the customer and sent to the manufacturing site for evaluation.The manufacturing site reports: the visual examination revealed that the locking mechanism (groove area) was deformed and damaged, and the groove was worn out.These marks reveal that the device has been used multiple times by the end user, and they are indicative of increased wear or groove is worn out.The functional inspection was performed per laryngoscope handle ifu by pushing downward on the blade to release it from the handle.The blade and handles were reattached and disassembled multiple times, and it was noted that there is light flickering as reported in the complaint.The complaint cannot be confirmed because there were deep scratch marks noted on the internal locking mechanism of the handle, and the locking mechanism was found to be damaged.These marks reveal that the device has been used multiple ti mes by the end user, and they are indicative of increased wear, and the groove is worn out.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Manufacturer conclusion: based on the functional testing performed on the device it is found that the root cause is related to unintentional user error.The ifu for this product states "always inspect the devices for damage or increased wear.Do not re-use damaged or worn devices." teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
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