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Model Number 420093-11 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The unit has not been returned to isi for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the unit is returned and/or if additional information is received.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 prograsp forceps broke off and 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 fragment to fall inside the patient.
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Event Description
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It was reported that during a da vinci-assisted total benign hysterectomy procedure, a fragment from the prograsp forceps instrument broke off and fell inside the patient.On 10/13/2017, intuitive surgical, inc.(isi) followed up with the isi clinical sales representative (csr) and obtained the following additional information: the csr stated that one of the jaws of the instrument broke off and fell inside the patient.An x-ray was taken to locate the fragment and 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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Search Alerts/Recalls
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