BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RITLENG PROBE

    MDR report key: 2578207 · Received May 3, 2012

    Report

    Report Number
    9615745-2012-00001
    Event Type
    Malfunction
    Date Received
    May 3, 2012
    Date of Event
    March 2, 2012
    Report Date
    April 30, 2012
    Manufacturer
    FCI SAS
    Product Code
    OKS
    PMA / PMN Number
    K940508
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING PRECAUTION: NOTE OF CAUTION: WHILE THE RITLENG PROBE (B)(4) IS SOMEWHAT FLEXIBLE, CARE SHOULD BE TAKEN TO AVOID ACTUAL BENDING WHICH COULD STRESS THE METAL AND CAUSE POSSIBLE BLOCKAGE. ALL INSTRUMENTS SHOULD BE INSPECTED CAREFULLY PRIOR TO ANY PROCEDURE AND SHOULD NOT BE USED IF ANY BENDING IS VISIBLE. THE EVENT WAS REPORTED BY THE HOSPITAL AND CAN BE LOCATED IN THE MAUDE DATABASE UNDER REPORT NUMBER (B)(4). THE MFR'S DISTRIBUTOR/IMPORTER SENT SEVERAL WRITTEN AND TELEPHONE REQUESTS TO THE HOSPITAL FOR ADD'L INFO AND RETURN OF THE DEVICE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED TO THE MFR'S DISTRIBUTOR/IMPORTER AND NO FURTHER INFO IS AVAILABLE REGARDING THIS EVENT. TO THE BEST OF THE MFR'S AND DISTRIBUTOR'S KNOWLEDGE, THE BROKEN PROBE DID NOT RESULT IN A SERIOUS INJURY NOR DID IT REQUIRE SURGICAL INTERVENTION. NEVERTHELESS, THIS EVENT IS BEING VOLUNTARILY REPORTED BY THE MFR AND THE MFR'S DISTRIBUTOR/IMPORTER.

    Description of Event or Problem · 1

    MFR'S DISTRIBUTOR/IMPORTER REC'D A REPORT FROM A SUB-DISTRIBUTOR WHO REC'D A REPORT FROM A HOSPITAL THAT A RITLENG PROBE ((B)(4)) HAD BROKEN DURING SURGERY, LEAVING A SMALL PIECE IN THE PT'S TEAR DUCT. PER MEDWATCH REPORT NUMBER (B)(4) FILED BY THE USER FACILITY, A PT WAS UNDERGOING A SURGICAL PROCEDURE FOR PROBLEMS WITH BALLOON DACRYOPLASTY IN THE LEFT EYE WITH POSSIBLE RITLENG TUBE PLACEMENT IN THE LEFT EYE. THE RITLENG PROBE ((B)(4)) INTRODUCER BROKE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RITLENG PROBE LACRIMAL PROBE OKS FCI SAS

    Patients

    Seq Age Sex Outcome Treatment
    1