BEUDAMED
    FDA Adverse Event Death Summary report: N

    HER OPTION PROBE

    MDR report key: 2338458 · Received November 11, 2011

    Report

    Report Number
    1216677-2011-00020
    Event Type
    Death
    Date Received
    November 11, 2011
    Date of Event
    October 12, 2011
    Report Date
    November 9, 2011
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HER OPTION PROBE WAS NOT RETURNED TO COOPERSURGICAL FOR EVALUATION AND THERE WAS NO LOT# PROVIDED. DR. CHAPPELL CALLED THE REGIONAL SALES REPRESENTATIVE REGARDING A PATIENT DEATH AND SEEKING SPECIFIC INFORMATION REGARDING HER OPTION PROCEDURE PROTOCOLS NOT TO FILE AN ACTUAL DEVICE FAILURE REPORT OR COMPLAINT. A QUERY OF OUR COMPLAINT DATABASE DID NOT REVEAL ANY OTHER DEATHS ASSOCIATED WITH THE HER OPTION PROBE. SHOULD THE HER OPTION PROBE BE RETURNED TO COOPERSURGICAL AT A LATER DATE, WE WILL PROVIDE A DEVICE EVALUATION FOLLOW UP TO FDA. (B)(4).

    Description of Event or Problem · 1

    AS DESCRIBED BY THE PHYSICIAN, DR. (B)(6): I DID HER OPTION ON A PATIENT THAT I HAD DONE ROLLERBALL ON OVER A YEAR PRIOR. SHE DECLINED HYST ETC. TWO WEEKS LATER SHE PRESENTS TO ER WITH FEVERS AND LEUKOCYTOSIS AND WENT DOWNHILL FAST IN ICU. SHE APPEARED SEPTIC IN DIC. CT ONLY SHOWED THICKENED TRANSVERSE COLON SO SURGEONS WENT IN L/S TO EVALUATE. I WAS CALLED IN AND SAW WHAT THE SURGEONS CALLED A "DUSKY UTERUS" WITH NO EVIDENCE OF PERFORATION, NORMAL BOWEL, NEGATIVE PERITONEAL FLUID CULTURES. HER PLATELETS WERE 22,000 AND SHE WAS VERY UNSTABLE. NOT KNOWING THE SOURCE OF HER SEPTIC PICTURE WE DIDN'T DO HYST AND SHE EVENTUALLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HER OPTION PROBE NONE MNB COOPERSURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death