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(b)(4).Date sent: 2/6/2024 b3: event year only reported: 2024 d4 lot numbers: potential: x70242, x7034x, x7030r, x7026v d4 batch #: unknown attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: what is the surgeon¿s experience with this device for this procedure? was the original procedure done in an open traditional manner or minimally invasive approach? if minimally invasive, can the approach/procedure be described in detail? what anatomical structures was the device used on? were the larger laryngeal blood vessels clipped and/or tied or was the harmonic used for ligation on those vessels? if the harmonic was used on the larger laryngeal blood vessels, what power level was used on the generator? were there any generator alert screens in the original procedure? can a generator log be pulled for engineering review? was the post op bleeding source identified? if yes, was it a vessel where the device was used? what was done in the secondary procedures to address the hematoma? were any blood products given to the patient after the hematoma was discovered? what is the patient's current status? is the rep and/or surgeon interested in a call to speak with ethicon medical and engineering? additional information was requested and the following was obtained: there were 3 different bring backs from 3 different cases.There were no issues with the 3 devices during the initial 3 cases the lot numbers of the devices were not recorded during the initial procedures but the potentially used lot numbers were added to the complaint so a dhr analysis could be performed for each lot.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the potential finished device lot numbers, and no non-conformances were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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, or its employees that the report constitutes an admission that the product, ethicon, 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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