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1 record match for Intuitive Surgical, Inc.
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Not graded by the source2000-10-31FDA MAUDEda Vinci Surgical System2955842-2012-00446da Vinci Surgical System
da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2012, INTUITIVE SURGICAL RECEIVED A PATIENT STORY POSTED ON THE INTERNET CONCERNING THEIR DA VINCI HYSTERECTOMY SURGICAL PROCEDURE: THE PATIENT INDICATED THAT ON (B)(6) 2000 SHE UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE AT (B)(6) HOSPITAL (LOCATION UNKNOWN) AND DURING THE SURGICAL PROCEDURE HER BLADDER WAS NICKED. THE PATIENT INDICATED THAT PRIOR TO THE SURGICAL PROCEDURE; SHE WAS ADVISED TO UNDERGO A HYSTERECTOMY WITH CYSTOCELE AND RECTOCELE REPAIR. THE PATIENT INDICATED THAT HER DOCTOR ADVISED HER THAT HER BLADDER DURING THE SURGICAL PROCEDURE WAS NOT ADDRESSED BECAUSE IT HAD DESCENDED TO A LEVEL 3, HER CERVIX WAS NOT REMOVED AND THE RECTOCELE WAS REPAIRED. THE PATIENT INDICATED THAT 2 DAYS POST OP SHE WAS RELEASED FROM THE HOSPITAL AND THAT SHE DID NOT RECOVER FROM THE SURGICAL PROCEDURE. THE PATIENT INDICATED FOR 7 DAYS AFTER THE DA VINCI SURGICAL PROCEDURE, HER BLADDER WOULD HARDEN AND SHE FELT AS THOUGH SHE WAS EXPERIENCING END STAGE LABOR AND HAD TO SEEK A SPECIALIST FOR HER BLADDER. THE PATIENT INDICATED THAT EXAMINATION BY THE SPECIALIST FOUND THAT HER BLADDER EXHIBITED EXTENSIVE SCARRING, MUSCLE DAMAGE AND THERE WAS NO EVIDENCE OF RECTOCELE REPAIR. THE PATIENT
cause not established2955842-2012-00446Intuitive Surgical, Inc.da Vinci Surgical SystemRead the record ↗