BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITESTAR PHACO HANDPIECE

    MDR report key: 19873285 · Received July 31, 2024

    Report

    Report Number
    3012236936-2024-000212
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    December 2, 2023
    Report Date
    July 31, 2024
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2, A3, A4 AND A5: DOB, AGE, SEX, GENDER, WEIGHT, RACE AND ETHNICITY: UNKNOWN/ NOT PROVIDED. SECTION D6A/D6B - NA AS THIS IS NOT AN IMPLANTABLE DEVICE. SECTION E1: FIRST NAME, LAST NAME, EMAIL ADDRESS: UNKNOWN. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; 690697A THAT HAS A SIMILAR DEVICE, 690705(A) WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER 510(K) # K981116. SECTION H3: AT THE TIME OF THE INVESTIGATION, PRODUCT WAS NOT AVAILABLE FOR EVALUATION AT JJSV IRVINE, HOWEVER PRODUCT WAS EVALUATED BY TECHNICIAN DURING FIELD SERVICE. IF PRODUCT IS RECEIVED AT JJSV IRVINE AND PRODUCT EVALUATION IS REQUIRED, THIS INVESTIGATION RECORD WILL BE REOPENED TO DOCUMENT PRODUCT EVALUATION RESULTS. FIELD SERVICE WORK ORDER WAS REVIEWED AND PRODUCT WAS EVALUATED BY FIELD SERVICE TECHNICIAN DURING SERVICE OF THE COMPACT INTUITIVE CONSOLE AND FOUND THAT THE SURFACE OF THE SUSPECT HANDPIECE WAS HIGHER THAN NORMAL AND ORDERED A REPLACEMENT. FIELD SERVICE HISTORY FOR THE LAST 12 MONTHS AGAINST THIS SERIAL NUMBER WAS PERFORMED ON 07/12/2024 AND NO RELATED SERVICE NOTIFICATION WAS FOUND. NO RELATED DEVIATION, NCMR, NC OR CAPA WAS INITIATED DURING THE MANUFACTURING PROCESS OF THE REPORTED SERIAL#. THE DEVICE MEETS MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASE. BASED ON THE INFORMATION OBTAINED, MALFUNCTION IS CONFIRMED, HOWEVER, PRODUCT DEFICIENCY CANNOT BE CONFIRMED AS THE HANDPIECE WAS MANUFACTURED IN 2022 AND THE HANDPIECE MET SPECIFICATIONS AT THE TIME IT WAS RELEASED. PER SUPPLIER RISK ASSESSMENT FOR MOOG HANDPIECES, HAZARD ITEM F4, "FAILS TO OPERATE OR POOR PERFORMANCE (UNIT DOES NOT COMPLY WITH REQUIREMENTS)", LOSS OR DETERIORATION OF FUNCTION, THE RELATIVE RESIDUAL RISK RATING HAS BEEN IDENTIFIED AS MEDIUM. AS THERE WAS NO PATIENT IMPACT AND THE REPORTED ISSUE IS NOT RELATED NC/CAPA ISSUE DURING THE MANUFACTURING PROCESS, NO FAILURE INVESTIGATION IS REQUIRED. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE SURGEON FELT THE SURFACE TEMPERATURE OF THIS PHACO HANDPIECE WAS HIGHER THAN OTHERS. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983313 WHITESTAR PHACO HANDPIECE UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. 690697A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose