(b)(4).Date sent: 4/17/2024.D4: batch #: unk.Additional information was requested and the following was obtained: "the patient is recovering after re-operation to remove the tip of the trocar on (b)(6) 2024.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) yes.The tip of the trocar was detected via ultrasound in the subcutaneous tissue of the patient.This required re-operation on (b)(6) 2024." 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 was the procedure? what is the surgeons experience with device? what was the anatomical position of this specific port? is it possible the trocar point made contact with the ribs upon insertion? were there any other intra op complications? were any deficiencies noticed before or during device use? was there excessive torquing of the instrument? what instruments were passed through the trocar? does the account use reprocessed trocars or does the account reprocess the trocars in house at the account? what is the current patient status? will device be returning for analysis? if it has been shipped, please provide tracking information." an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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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