It was reported that during set-up.The cl-tr third cann 5mm/76mm ltx free (10) b had one obturator missing from the package.Instead, two trocars were packed.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Internal complaint reference (b)(4).H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was not returned in its original packaging.There were two trocars and a cannula present, but the obturator was missing.The tip protectors were not present on either trocar.There was no debris.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the drawing found that the trocar, obturator, and cannula were specified to be packaged in the same pouch.The trocar was equipped with a tip protector.The complaint was confirmed, but the root cause could not be established since the set was not returned in unmodified packaging.Factors that could have contributed to the reported event include mix up of sets, re-use of device leading to mixed products, or a packaging problem prior to arrival at the customer site.
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