BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKG, SLIDING LOCK ATRAUMATIC GRASPER

    MDR report key: 2915525 · Received January 9, 2013

    Report

    Report Number
    2936485-2013-90014
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    KOG
    PMA / PMN Number
    K973259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE GRASPER UNIT WAS REMOVED FROM THE SURGICAL FIELD AND REPLACED WITH A DIFFERENT GRASPER UNIT. THERE WAS, AT THE MOST, A FIVE MINUTE DELAY. ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. NOTE: THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF A LAPAROSCOPIC ADRENALECTOMY PROCEDURE, THE DOCTOR PLACED ONE OF THE NEW TROCARS THAT SHE WAS TRIALING INTO THE PT AND INSERTED THE GRASPER UNIT INTO THE TROCAR. ONCE SHE BEGAN TO MANIPULATE THE UNIT INSIDE THE PT, SHE SAID IT WAS STUCK (THE UNIT WAS STUCK IN THE TROCAR). SHE THEN REMOVED THE UNIT, ALONG WITH THE TROCAR, AND REALIZED THAT THE GRASPER UNIT HAD TWO PIECES OF COATING MISSING. THE DOCTOR LOOKED IN THE PT'S ABDOMEN AND FOUND AND REMOVED ONE OF THE MISSING PIECES. THE SECOND PIECE WAS NOT LOCATED. THE DOCTORS DECIDED THAT THE MISSING PIECE WAS INSIGNIFICANT ENOUGH THAT IT WOULD NOT POSE THREAT TO THE HEALTH OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12094 PKG, SLIDING LOCK ATRAUMATIC GRASPER KOG STRYKER ENDOSCOPY SAN JOSE 1241948

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK