(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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) 2020.According to the complainant, during the procedure, the ultrasound probe broke and was unable to remove the broken probe from the handpiece.Nothing detached inside the patient.The procedure was cancelled due to this event.There was no serious injury/adverse effect to patient as a result of the event.
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