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It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, a needle tip was found to be missing and could not be located visually within the operative field.Per protocol, an intraoperative x-ray was immediately obtained.The image revealed a small radio-opaque dot, indicating the location of the missing fragment.Based on the x-ray findings, the specific tissue where the dot was located was excised.A repeat x-ray of the surgical site was then performed.The second image confirmed that the radio-opaque dot was no longer present, ensuring the fragment was successfully removed.Additional information.
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Product complaint # (b)(4) 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.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.Was the needle retrieved from the patient during the initial procedure? if not, please explain.What measures were taken to retrieve the needle? was there any additional tissue damage as a result of searching for the needle? how long was the delay? please specify in minutes.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? what is the most current patient status? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? for the original intended closure, how were all layers closed? how was the suture placed (interrupted or continuous)? what instruments were used to grasp the needle? where was the needle grasped during use? were the needle piece(s) retrieved during the same procedure? if not, please explain.Please describe any medical/surgical intervention required for this suture event including dates and results.Which tissue was the dot seen on x-ray and excision performed on? was additional dissection required in other tissues other than the target tissue? if yes, please describe.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name?.
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