There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8103004, medical device expiration date: 2023-04-30, device manufacture date: 2018-04-13.Medical device lot #: 8103006, medical device expiration date: 2023-04-30, device manufacture date: 2018-04-13.Medical device lot #: 8138084, medical device expiration date: 2023-05-31, device manufacture date: 2018-05-18.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Investigation: a device history review was conducted for lot number 8103004, 8103006, and 8138084.Our records show that this is the only instance of this issue occurring in any of these production batchs.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Although photos were submitted for evaluation, clearly displaying the reported failue mode.Unfortunately, the root cause for this complaint could not be determined without the return of the affected device.
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