BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER WAND HOLDER

    MDR report key: 1726951 · Received June 3, 2010

    Report

    Report Number
    3007323246-2010-00001
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 19, 2010
    Manufacturer
    I2S MICRO IMPLANTABLE SYSTEMS LLC
    Product Code
    GZL
    PMA / PMN Number
    K042384
    Removal / Correction Number
    3007323246-3/24/10-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER DID NOT INDICATE WHICH SERIAL NUMBER OF WAND HOLDER WAS USED; BOTH SERIAL NUMBERS (B)(4) WERE RETURNED. BOTH DEVICES HAD THE DIMENSION STACK UP CONCERN AND WOULD NOT HOLD THE INSERTER TIGHTLY. EVALUATION SUMMARY: THE FAILURE WAS DUPLICATED IN-HOUSE WITH CURRENT WAND HOLDERS AND INSERTERS. BOTH THE INSERTER AND THE HOLDER ARE WITHIN THEIR SPECIFICATIONS. BOTH THE INSERTER AND THE HOLDER PARTS HAVE THE SAME TOLERANCES OF 0.375" +/- 0.005. IT WAS FOUND THAT THE INSERTER OUTER DIAMETER CANNOT BE LESS THAN 0.002" OF THE INTERNAL DIAMETER OF THE HOLDER OR IT WILL NOT HOLD THE WAND TIGHT.

    Description of Event or Problem · 1

    THE WAND HOLDER COULD NOT BE TIGHTENED ENOUGH TO SECURELY HOLD THE INSERTER WAND FOR ONCE CUSTOMER. IF THE WAND HOLDER CLAMP IS NOT SECURED TIGHT ENOUGH, THERE IS SOME RISK THAT THE WAND COULD SLIP THROUGH THE WAND HOLDER AND CONTACT THE BRAIN. THERE WAS NO REPORT OF PATIENT INJURY. NOTE: THE DENVER DISTRICT OFFICE OF FDA WAS NOTIFIED OF THE RECALL OF THE AFFECTED WAND HOLDERS. THE FDA DISTRICT OFFICE ISSUED RECALL NUMBER: Z-1619-2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSERTER WAND HOLDER HOLDER GZL I2S MICRO IMPLANTABLE SYSTEMS LLC 4273

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NEUROPORT ARRAY| INSERTER