BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOVEREIGN COMPACT CONSOLE

    MDR report key: 2981466 · Received February 27, 2013

    Report

    Report Number
    2020664-2013-00018
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS NOT EVALUATED AS THERE WAS REPORT OF MALFUNCTION HOWEVER, PHACO SPECIALIST VISITED THE SITE TO PERFORM IN-SITU OBSERVATION AS REPORTED IN THE INITIAL REPORT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). MANUFACTURING YEAR 2003. PHACO SPECIALIST VISITED THE SITE TO PERFORM IN-SITU OBSERVATION. SHE OBSERVED 14 SURGICAL CASES AND PATIENT WORK-UP AND WITNESSED POOR HAND HYGIENE (STAFF MEMBERS USING THEIR SMART PHONES AND NOT WASHING THEIR HANDS AFTER SETTING DOWN THE PHONE), SURGEON WAS NOT SCRUBBING IN-BETWEEN CASES (AS IT SHOULD), PERSONNEL WAS NOT FOLLOWING THE DIRECTIONS FOR USE TO CLEAN THEIR REUSABLE TUBING PACKS AND THEY WERE NOT REMOVING THE PHACO TIP AFTER CLEANING IT AND FOR STERILIZATION. SHE REPORTED BACK HER FINDINGS TO THEIR FACILITIES RISK MANAGER (RM) AND OR ADMINISTRATOR. THEY KNEW PERSONNEL WAS USING SMARTPHONES AND WERE SURPRISED THAT THEY CONTINUED WITH THE PRACTICE AFTER BEING TOLD NOT TO. THEY WERE ALSO AWARE THE SURGEON DID NOT SCRUB IN-BETWEEN CASES AND WILL ADDRESS THE ISSUE. STAFF MEMBER WAS RE-TRAINED BY PHACO SPECIALIST ON HOW TO CLEAN REUSABLE TUBING PACKS. ACCOUNT REPORTED PATIENTS HAVE NOT IMPROVED MUCH. THE RM HAD A SAMPLE SENT FOR ANALYSIS FOR THE POSSIBLE CAUSE OF THE TASS. THEIR INDEPENDENT ANALYSIS OF THE SAMPLE SHOWED COPIOUS VANCOMYCIN (CAUSTIC CONCENTRATION) NOTE: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THIS TIME HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTION TYPOGRAPHICAL ERROR. ACTUAL DEVICE WAS NOT EVALUATED AS THERE WAS NO REPORT OF MALFUNCTION HOWEVER, PHACO SPECIALIST VISITED THE SITE TO PERFORM IN-SITU OBSERVATION AS REPORTED IN THE INITIAL REPORT. PLACEHOLDER.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THAT PATIENT EXHIBITED SIGNS AND SYMPTOMS OF TASS (TOXIC ANTERIOR SEGMENT SYNDROME), CORNEAL EDEMA AND YELLOW PRECIPITATIONS ON CORNEA AND IRIS (HYPOPYON). ADDITIONAL POST-OPERATION THERAPY REQUIRED EXTENSIVE STEROID DROPS (NO NAME PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85459 SOVEREIGN COMPACT CONSOLE SOVEREIGN COMPACT HQC ABBOTT MEDICAL OPTICS CMPR680300

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other