(b)(4).Batch # x94f6x.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.The device was returned sealed inside its original packaging.Upon visual inspection, a yellow stain was identified on the tyvek.In addition, a cut was noted on the tyvek as if a sharp object damaged it.The reported event is confirmed.Due to the damage and stains found on the packaging, a possible cause for this condition is due to improper handling during transit or storage.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot x94f6x, and no non-conformances were identified.
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