The device was received for evaluation.The unit was inside of the pouch, which was unsealed; however, the impression of the sealing jaws were evident on the pouch, indicating that the pouch had gone through the sealing process.The dispenser hoop, pusher, introducer and implant coil were undamaged and appeared to be within specification.The reported complaint is confirmed.The investigation of the returned device found the pouch to be open; however, the impression of the sealing jaws were evident on the pouch, indicating that the pouch had gone through the sealing process.The build record for the lot was found to be complete and accurate.The pouch seal is inspected in-process by manufacturing and 100% by quality control.In addition, the pouch seal strength is monitored routinely as part of the pouch sealing process using peel test and burst test.There have been no other complaints associated with this lot.The findings from this investigation have been communicated to manufacturing and quality.
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