BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNT 1352277 QUICK-LOCK SPECULUM

    MDR report key: 13742950 · Received March 12, 2022

    Report

    Report Number
    3014334038-2022-00049
    Event Type
    Malfunction
    Date Received
    March 12, 2022
    Date of Event
    February 17, 2022
    Report Date
    March 25, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    FXG
    UDI-DI
    10381780074526
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE QUICK-LOCK SPECULUM MOUNT (1352277) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS - EVALUATION WAS UNABLE TO CONCLUSIVELY VERIFY CUSTOMER INFORMATION AS VALID. THE MOUNT WAS UNDAMAGED AND NO DEFECT WAS FOUND. TESTED WITHIN SPECIFICATIONS. ROOT CAUSE - THE RETURNED 1352277 MOUNT IS IN USED CONDITION WITH NO VISIBLE DEFECT. THE MOUNT WAS ATTACHED TO A BROKEN 1352275 SPECULUM ARM. THE ARM IS BEING INVESTIGATED UNDER A SEPARATE COMPLAINT. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Description of Event or Problem · 0

    THIS IS 1 OF 3 LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00048, 3014334038-2022-00050. A FACILITY REPORTED THAT THE QUICK-LOCK SPECULUM MOUNT (1352277) BROKE IN THE MIDDLE OF A TYMPANOPLASTY PROCEDURE. ALL PARTS WERE RECOVERED AND WERE TAKEN OFF THE SURGICAL FIELD; NO FRAGMENTS FELL INTO THE SURGICAL SITE. IT WAS REPORTED THAT AN X-RAY WAS PERFORMED TO ASSURE THAT NO PARTS WERE LEFT IN THE PATIENT FOLLOWING THE EVENT. THE EVENT DID NOT LEAD TO PATIENT INJURY, DEATH, OR DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184318 MOUNT 1352277 QUICK-LOCK SPECULUM PFM11 FXG INTEGRA LIFESCIENCES MANSFIELD 1352277 10381780074526

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown