BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMINAR

    MDR report key: 15840902 · Received November 21, 2022

    Report

    Report Number
    3012236936-2022-02865
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    October 27, 2022
    Report Date
    February 23, 2023
    Manufacturer
    FLEXTRONICS MEDICAL
    Product Code
    HQC
    UDI-DI
    05050474500389
    PMA / PMN Number
    K844373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER: YES RETURNED TO MANUFACTURER DATE: 11/14/2022 DEVICE EVALUATED BY MANUFACTURER? YES SECTION H6 CODING TYPE OF INVESTIGATION: 10 INVESTIGATION FINDINGS: 213. DEVICE EVALUATION: 1 OPENED OPOS20L PHACO IRRIGATION SLEEVE AND TIP WERE RECEIVED WITHIN A RESEALABLE BAG. A VISUAL INSPECTION OF THE RETURNED PRODUCT DID NOT REVEAL ANY OBVIOUS DEFECTS OR DAMAGE. THE PHACO TIP AND SLEEVE WERE ATTACHED TO A KNOWN GOOD PHACO ELLIPS FX HANDPIECE. THE TIP AND SLEEVE WERE NOT FOUND TO BE LOOSE AND THE PHACO TIP COULD NOT BE REMOVED BY HAND. THE RETURNED TIP AND SLEEVE WERE ATTACHED TO AN ELLIPS FX PHACO HANDPIECE (E202839) AND A KNOWN GOOD OPO73 PHACO PACK (LOT# 60212251) ON THE WHITESTAR SIGNATURE PRO. PRIME/TUNE WAS COMMENCED AND COMPLETED SUCCESSFULLY. THE TIP AND SLEEVE WERE NOT FOUND TO BE LOOSE AND THE PHACO TIP COULD NOT BE REMOVED BY HAND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT, NO RELATED NON-CONFORMITY OR DEVIATIONS WERE ISSUED DURING MANUFACTURING. ALL DEVICES MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER TELEPHONE NUMBER: (B)(6). DEVICE EVALUATED BY MFR: OTHER (81): A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PHACO TIP WAS LOOSENED DURING PHACO PROCEDURE. CUSTOMER WAS ABLE TO DETACH THE TIP FROM HANDPIECE BY HAND. THE ALLEGED PRODUCT WAS REPLACED WITH A BRAND NEW PHACO TIP. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE BACKUP. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1758753 LAMINAR UNIT, PHACOFRAGMENTATION HQC FLEXTRONICS MEDICAL OPOS20L 60302979 05050474500389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ELLIPS FX HANDPIECE