(b)(4).Date sent to fda: 12/02/2020.The device history record for ugy1811078 was reviewed for non-conformances related to the nature of the complaint during the manufacturing process.The results of this review indicate there were zero non-conformances regarding the nature of the complaint associated with this lot.Product release date: november 2018.Product expiry date: november 2023.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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(b)(4) date sent to fda: 05/12/2021 this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: d9, h3, h6 h3 analysis summary: the device has not been returned in its original packaging.The device shows no signs of activation.The shaft is in good condition with no damage or distortion.The rubber seal has not been returned to allow investigation.The customer claimed that the shaft seal was broken which caused a lot of leakage.Inspection of the device revealed that the seal was missing and had not been returned.The device shaft remained in good condition with no signs of damage or sharp edges that could have contributed to the claimed seal damage.As the seal was not returned for inspection it is not possible to identify a root cause for the seal damage.(b)(4) date sent to fda: 05/12/2021 this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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