BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE SYSTEM

    MDR report key: 6806223 · Received August 19, 2017

    Report

    Report Number
    3006695864-2017-00643
    Event Type
    Injury
    Date Received
    August 19, 2017
    Date of Event
    July 24, 2017
    Report Date
    September 25, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    UDI-DI
    05050474534476
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT SIGNIFICANT CHANGE OVER HISTORICAL COMPLAINT LIMITS AND NO RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). MANUFACTURING YEAR 2014. FIELD SERVICE SPECIALIST (FSS) CHECKED SYSTEM WITH A SERVICE HANDPIECE AND OPO71 TUBE PACK AND THEN ALSO WITH 3 OF THE CUSTOMER´S HANDPIECES AND THEIR LAST OPO71 USED IN THE LAST SURGERY AND ALL WORKED FINE. THE SYSTEM MET ALL AMO SPECIFICATIONS IN ALL CASES. THE STAFF REPORTED TO THE FSS THAT THE FOOTPEDAL WAS USUALLY VERY WET WITH SALINE SOLUTION DURING SURGERIES AND IT WAS FAILING INTERMITTENTLY. WHILE CHECKING THE SURGEON¿S SYSTEM SETTINGS FSS NOTICED THE PHACO POWER AT P3 WAS AT 100% INSTEAD OF THE USUAL 75% ON THE FOOTPEDAL VERTICAL MOVEMENT. FSS TOOK IT BACK TO THE 75% SET UP AND SYSTEM WORKED FINE. A NEW FOOTPEDAL WAS SUPPLIED AS ACCESSORY EXCHANGE AND A SIGNATURE WAS LOANED FOR BACK UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CATARACT PROCEDURE THE FOOTPEDAL SENT BACK THE CONTENT TO THE EYE, THERE WAS NO VACUUM, AND THE SYSTEM DID NOT RESPOND. ACCOUNT MENTIONED THAT WHEN PRESSING THE FOOTPEDAL THE SYSTEM WORKS INTERMITTENTLY WITH VACUUM AND PHACO. PATIENT PRESENTED WITH DIFFUSED CORNEAL EDEMA POST TREATMENT AND SECONDARY SURGICAL OR MEDICAL INTERVENTION IS PENDING PATIENT PROGNOSIS. THE PROCEDURE WAS DELAYED FOR 45 MINUTES FOR THIS PATIENT. VISUAL ACUITY PRE-OPERATIVE: 0,05; VISUAL ACUITY POST-OPERATIVE: ABLE TO COUNT FINGERS AT 20CM. THIS REPORT IS FOR THE SYSTEM. A SEPARATE REPORT IS BEING SUBMITTED FOR THE FOOTPEDAL CONCOMITANT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586438 WHITESTAR SIGNATURE SYSTEM PHACOFRAGMENTATION UNIT HQC ABBOTT MEDICAL OPTICS NGP680300 05050474534476

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other