BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    60 DEG SUTURE GRASPER

    MDR report key: 1791873 · Received August 4, 2010

    Report

    Report Number
    1221934-2010-00273
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    August 27, 2009
    Report Date
    July 28, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS MEDWATCH IS TO DOCUMENT THIS EVENT BECAUSE THE DISTAL TIP OF A SUTURE GRASPER FELL INTO A PATIENT¿S BODY. AT THIS POINT IN TIME NO REVISION SURGERY HAS BEEN PERFORMED. A BATCH HISTORY REVIEW CAN¿T BE DONE BECAUSE A LOT/BATCH NUMBER WAS NOT PROVIDED. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    DURING SURGERY, THE TIP OF THE PRODUCT HAD BECOME DEFORMED, AFTER THE DOCTOR REMOVED THE PRODUCT FROM PATIENT BODY, THE TIP OF THE PRODUCT WAS FOUND MISSING. AT THE END OF THE SURGERY, IT WAS FOUND THROUGH X-RAY THAT THE TIP OF THE PRODUCT REMAINED IN THE PATIENT¿S BODY. THE TIME OF THE SURGERY WAS EXTENDED BY 30 MINUTES. NO REVISION SURGERY HAS BEEN PERFORMED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60 DEG SUTURE GRASPER MITEK SUTURE GRASPER HRX DEPUY MITEK 251723 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR