BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXTRUS SMALL ACCESS RETRACTOR

    MDR report key: 3211800 · Received July 8, 2013

    Report

    Report Number
    3005075853-2013-03432
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K070198
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THIS IS A RESUBMITTAL OF A SUPPLEMENTAL MEDWATCH SENT ON (B)(6) 2013. ADDITIONAL INFORMATION: MULTIPLE REQUESTS FOR RETURN OF DEVICE HAVE BEEN MADE BUT NO DEVICE HAS BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE, WHEN THE OPERATOR INSERTED HIS HAND IN THE DEVICE, THE VALVE BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLECTOMY PROCEDURE, WHEN THE OPERATOR INSERTED HIS HAND IN THE DEVICE, THE VALVE BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308865 DEXTRUS SMALL ACCESS RETRACTOR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1