The complainant was unable to provide the upn and device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported the device was not used past its expiry date.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 for a percutaneous nephrolithotomy procedure on an unknown date.According to the complainant, during the procedure the device caused a perforation in the kidney.There was some bleeding that did not require treatment; however, the procedure was unable to be completed due to this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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