BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY SUPER 90-S

    MDR report key: 3854298 · Received June 6, 2014

    Report

    Report Number
    0002936485-2014-00393
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE TIP BREAKING CONDITION WAS NOT CONFIRMED SINCE THE UNIT WAS NOT RETURNED. THE PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT ARE NOT LIMITED TO: 1. NON CONFORMING COMPONENT. ACCORDING TO THE DEVICE HISTORY RECORD REVIEW, THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. 2. POOR ASSEMBLY PROCESS. IN ADDITION, A 30X INSPECTION OF THE PROBE¿S TIP ASSEMBLY IS PERFORMED ON ALL THE PROBES DURING MANUFACTURING. THE ACTIVATION HISTORY COULD NOT BE RETRIEVED SINCE THE UNIT WAS NOT RETURNED FOR EVALUATION. 3. MISUSE. THE PROBE IS DELIVERED INSIDE A BLISTER IN WHICH THE UNIT IS SNAPPED IN PLACE, AND THE BLISTER IS PLACED INSIDE A BOX, WHICH PROVIDES PROTECTION TO THE TIP OF THE PROBE. IF THE PROBE IS DELIVERED TO THE CUSTOMER WITH A DAMAGE ON THE TIP, THEN THE UNIT MUST BE DISCARDED BEFORE USE. IT IS POSSIBLE THAT THE UNIT WAS USED AS A TOOL FOR THE MECHANICAL DISPLACEMENT OF TISSUE OR BONE, OR USE THE PROBE AS A PRYING OR SCRUBBING TOOL, OR THAT EXCESSIVE FORCE WAS USED WHEN INSERTING OR REMOVING THE PROBE INTO AN OBSTRUCTED PASSAGEWAY AS THIS MAY RESULT IN DAMAGE TO THE TIP OF THE PROBE. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THEREFORE THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE UNIT BROKE OFF INSIDE THE SHOULDER. IT WAS NOT VISIBLE THROUGH THE SCOPE, SO AN X-RAY WAS USED TO RETRIEVE THE BROKEN PIECE FROM THE SHOULDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE UNIT BROKE OFF INSIDE THE SHOULDER. IT WAS NOT VISIBLE THROUGH THE SCOPE, SO AN X-RAY WAS USED TO RETRIEVE THE BROKEN PIECE FROM THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333135 SERFAS ENERGY SUPER 90-S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE 13240AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR