|
It was reported that a patient underwent a c-section procedure on (b)(6)2026 and suture was used.During an emergency cesarean section, following delivery of the infant and during the uterine closure using a vicryl plus suture, the surgeon passed the needle through the uterine wall twice with no difficulty and during the third pass felt an unusual resistance during needle passage through the tissue.The needle was inspected and the surgeon observed that the tip of the needle was broken.To be noted that according to the report, during suturing, only a needle holder was used, with no use of forceps or any other instrument.A thorough search was carried out in an attempt to check if the broken needle tip was in the suturing area, however, it was not located.The surgeon continued the procedure using another suture from the same box (same lot), and completed the uterine closure.According to the report, suturing was smooth without any difficulty or feeling of an unusual resistance.At the conclusion of the procedure, an abdominal x-ray was performed at the abdomen area and based on the finding no foreign body or needle fragment was identified on the imaging.The procedure was completed successfully.The suture will be returned to the manufacturer for examination together with the box from which it was taken out including all the remaining new sutures that remained in the box.There were no patient consequences reported.Additional information was requested.
|
|
Product complaint #(b)(4).Date sent to the fda: 8/27/2026.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.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:
1.Did this event contribute to any patient adverse event? if yes, please explain.2.Did the needle fall into the patient?
2.If yes, was the needle piece(s) retrieved during the same procedure?
3.What measures were implemented to retrieve the broken piece?
4.Was there any additional tissue damage resulting from the search for the needle piece?
5.Does a fragment of the needle remain in the patient¿s tissue?
6.If yes, was more than half the needle retained in the patient? is there any plan in place to remove the needle piece in the future? if yes, could you please provide the scheduled date for the removal?
7.In which tissue structure was the broken needle located?
8.What is the surgeon's opinion of the potential consequences for the patient?
9.Please provide the source or title of external person providing answers to follow-up:
the following information was reported:
according to the report, during an urgent cesarean section, after removing the newborn and at the stage of closing the uterus using the vicryl plus thread, the surgeon performed two transfers of the needle through the uterine wall without difficulty, and in the third transfer he felt unusual resistance when the needle passed through the tissue.The needle was examined and the surgeon noticed that the tip of the needle was broken.It should be noted that according to the report, during the sewing, only a needle holder was used, without the use of tweezers or other equipment.A thorough search was conducted in an attempt to check whether the needle fragment was in the suture area, but it was not located.The surgeon continued the operation, using another thread from the same box (and the same batch), and completed the closure of the uterus.According to the report, the sewing was carried out without difficulty or an unusual sense of resistance.At the end of the operation, an x-ray of the abdominal area was performed, and according to its findings, no foreign body or part of the needle was observed in the x-ray.The surgery was completed successfully.The needle will be returned to the manufacturer for testing along with the box from which it was removed, including the new needles left in the box.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.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
|
