The instrument has not been returned to isi for evaluation.Therefore, the root cause of the customer reported failure mode cannot be determined.If additional information is received, a follow-up mdr will be submitted.Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a fragment from the tenaculum forceps fell inside the patient.The fragment was retrieved and no additional surgical intervention was required.However, unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what caused the cable to fall inside the patient.
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It was reported that after completion of a da vinci-assisted myomectomy procedure, a fragment from the tenaculum forceps instrument broke off and fell inside the patient.The fragment was retrieved during the same da vinci procedure.The planned surgical procedure was completed and no patient harm, adverse outcome, or injury was reported.
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