BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER MULTIVAC 50 IFS

    MDR report key: 9896234 · Received March 29, 2020

    Report

    Report Number
    3006524618-2020-00137
    Event Type
    Malfunction
    Date Received
    March 29, 2020
    Date of Event
    March 6, 2020
    Report Date
    May 12, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470006551
    PMA / PMN Number
    K180848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H3,H6: THE DEVICE REPORTED, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. A RELATIONSHIP BETWEEN THE PRODUCT AND REPORTED INCIDENT CANNOT BE ESTABLISHED. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 2011312 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. A VISUAL INSPECTION AND FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND CUSTOMER´S COMPLAINT CANNOT BE CONFIRMED. POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO THE FAILURE REPORTED INCLUDE, BUT ARE NOT LIMITED TO: DEVICE COMING INTO ABRUPT CONTACT WITH A HARD (METALLIC) OBJECT, IMPROPER INSERTION OR REMOVAL FROM AN APPARATUS, USED AT A HIGHER THAN RECOMMENDED SET POINT OR EXCESSIVE FORCE APPLIED TO THE TIP. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY PART OF THE METAL SCREEN ON THE TIP OF THE WAND BROKE OFF INSIDE THE JOINT. A SHAVER WAS USED TO RETRIEVED THE SMALL FRAGMENT. NO PATIENT INJURIES OR SIGNIFICANT DELAY REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358524 AMBIENT SUPER MULTIVAC 50 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. ASHA4830-01 2011312 00817470006551

    Patients

    Seq Age Sex Outcome Treatment
    1