It was reported to karl storz that a patient's membrane was ruptured after surgery.The patient was pregnant with twins; however, the patient had twin-to-twin tranfusion syndrome (ttts) stage 3, a rare condition where one twin receives too much blood while the other twin receives too little blood.One twin had reversed blood flow in the umbilical artery, while the other twin had intermittent absent blood flow in the umbilical artery.The difference in growth between the twins was 18%.The patient also had large subchorionic hematoma.The patient underwent fetoscopic laser photocoagulation of placental anastomosis for ttts.The surgery was successful, but there were risks involved, such as membrane separation that could lead to premature rupture of membranes after the surgery and placental abruption.Without receiving fetoscopic laser photocoagulation surgery, the patient was at risk of losing one of both twins.After the surgery, the patient was found to have a significant amount of chorioamniotic separation but remained stable.Later that afternoon, the patient ruptured her membranes but remained stable.The patient was resealed and received latency antibiotics.The twins recovered from surgery with concordant fluid, bladder seen, and normal dopplers.On the 22 week and 1 day, the patient received c-section to deliver the twins because the patient had severe preeclampsia on the days prior.Both twins are in the nicu and stable.It was confirmed by the treating physician that karl storz devices were not malfunctioned and did not contribute to the complication.The physician believed that the complication was due to patient's previous subchorionic hematoma.
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Reported device would not be returned for evaluation because the physician believed there was no malfunction or no device contribution to the adverse event.Out of abundent for precautions and patient safety, this case will be documented and evaluated.Once the evaluation is complete, a supplemental report would be made to the fda.The event is filed under internal karl storz complaint id: (b)(4).
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