BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER FLEXIBLE CLIP APPLIER

    MDR report key: 2844267 · Received November 8, 2012

    Report

    Report Number
    3007593944-2012-00016
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    June 19, 2012
    Report Date
    June 19, 2012
    Manufacturer
    TRANSENTERIX, INC.
    Product Code
    OTJ
    PMA / PMN Number
    K091697
    Removal / Correction Number
    Z-2137-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION OF COMPLAINTS RELATED TO CLIP APPLIER FUNCTIONALITY, A NON-SAFETY RELATED QUALITY ISSUE WAS IDENTIFIED. THE DECISION WAS MADE TO RECALL THE CLIP APPLIER PRODUCT AND A RECALL WAS EXECUTED ON (B)(4) 2012. FDA WAS NOTIFIED ON (B)(4) 2012. RECALL NUMBER Z-2137-2012. DURING THE RECALL CLOSURE AND IN DISCUSSIONS WITH FDA ON 10/31/2012, IT WAS DETERMINED THAT MDRS SHOULD BE FILED TO ENSURE COMPLETE DOCUMENTATION. THIS MDR IS BEING FILED RETROSPECTIVELY.

    Description of Event or Problem · 1

    DURING AN ABDOMINAL LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGICAL SALES REP INDICATED THAT THE CLIP APPLIER HAD DIFFICULTY CLOSING CLIPS. THE CLIP APPLIER WAS NOT USED IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER FLEXIBLE CLIP APPLIER LAPAROSCOPIC, GENERAL AND PLASTIC SURGERY OTJ TRANSENTERIX, INC. 9000029 DC082122

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK