User facility/medwatch number: (b)(4).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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It was reported to boston scientific corporation that a lithoclast ultrasound probe was used during a percutaneous nephrolithotomy procedure in the kidney performed on (b)(6) 2019.According to the complainant, during the procedure, the ultrasound probe broke in half midway through the procedure and the broken piece was removed from the sterile field.The procedure was completed with another lithoclast ultrasound probe.There were no serious injury/adverse effect to patient as a result of the event.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available, a supplemental report will be submitted.
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