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Not graded by the source2014-12-31Press recordsIntuitive Surgical, Inc.
In addition, as further described in Note 7 to the Consolidated Financial Statements included in Part II, Item 8, we are currently named as a defendant in approximately 102 individual product liability lawsuits and a multi-plaintiff product liability lawsuit filed on behalf of 20 patients who underwent da Vinci Surgery.
cause not establishedIntuitive Surgical, Inc.Read the record ↗Not graded by the source2014-07-24FDA MAUDEAccuray2950679-2014-00008CyberKnife
CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY AN ACCURACY EMPLOYEE, THAT A FIELD SERVICE ENGINEER RECEIVED AN ELECTRICAL SHOCK WHILE SERVICING THE SYSTEM MODULATOR CABINET AT THE POINT OF THE CIRCUIT BREAKER THREE. THE FIELD SERVICE ENGINEER REPORTED BURNS ON HIS FINGERS AT THE POINT OF ENTRY, ALONG WITH HEART PALPITATIONS AND AN "UNUSUAL REACTION OF THE NERVOUS SYSTEM." THERE IS NO REPORT OF SERIOUS INJURY OR DEATH.
cause not established2950679-2014-00008AccurayRead the record ↗Not graded by the source2014-01-01FDA MAUDEAccuray3003873069-2022-00013CyberKnife
CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT CONTACTED ACCURAY AND PROVIDED THE FOLLOWING INFORMATION: HAD CYBERKNIFE TREATMENT IN 2014 AT (B)(6) HOSPITAL. SHORTLY AFTER THE TREATMENT THE I HAD URINARY INCONTINENCE FOLLOWED BY LATER FECAL INCONTINENCE. BOTH ARE UNCONTROLLABLE. THERE ARE SURGERIES TO HELP CORRECT THIS PROBLEM HOWEVER I DO NOT WISH TO GO THIS ROUTE AND VERY DISSATISFIED WITH THE OUTCOME.
cause not established3003873069-2022-00013AccurayRead the record ↗