BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    MDR report key: 3973893 · Received August 1, 2014

    Report

    Report Number
    0002936485-2014-00547
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 4, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GEI
    PMA / PMN Number
    K071859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. PROBABLE ROOT CAUSES FOR THE REPORTED CONDITION CAN BE ASSOCIATED, BUT ARE NOT LIMITED TO: NON CONFORMING COMPONENT. EVEN THOUGH THE DEVICE HISTORY RECORD OF THE REPORTED UNIT COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS NOT REPORTED, A POSSIBLE WORKMANSHIP (ASSEMBLY) RELATED CONDITION IS A LESS LIKELY TO BE A CONTRIBUTOR BASED ON THE LINE CONTROLS, NON-CONFORMANCE REPORT AND PREVIOUS COMPLAINT HISTORY RELATED TO THIS PART NUMBER OR CONDITION REPORTED. POOR ASSEMBLY PROCESS. 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. A POSSIBLE WORKMANSHIP (ASSEMBLY) RELATED CONDITION IS A LESS LIKELY POSSIBLE CONTRIBUTOR BASED ON THE LINE CONTROLS AND PREVIOUS COMPLAINT HISTORY. NO PREVIOUS SIMILAR CERAMIC TIP BREAKING CASES HAVE BEEN REPORTED FOR THIS PART NUMBER. 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. IN THE EVENT THAT THE PROBE IS DELIVERED TO THE CUSTOMER WITH A DAMAGED 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. THEREFORE, A POSSIBLE USER RELATED (MISUSE) POSSIBLE CONTRIBUTOR CANNOT BE RULED OUT. IN SUM, THE UNIT WAS NOT RETURNED AND THE FAILURE MODE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIFFICULTY RECOVERING THE BROKEN TIP, BUT THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT MEDICAL INTERVENTION, ADVERSE CONSEQUENCES OR SURGICAL DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIFFICULTY RECOVERING THE BROKEN TIP, BUT THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT MEDICAL INTERVENTION, ADVERSE CONSEQUENCES OR SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451047 3.5MM 90-S SERFAS ENERGY SUCTION PROBE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY-SAN JOSE NA

    Patients

    Seq Age Sex Outcome Treatment
    1