BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 7166614 · Received January 4, 2018

    Report

    Report Number
    2027111-2018-00007
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    November 24, 2017
    Report Date
    February 28, 2018
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    UDI-DI
    00607915110123
    PMA / PMN Number
    K062169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE EVENT UNIT, WHICH CONFIRMED THE REPORTED EVENT OF ROUGH ACTUATION. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY THE BLADE FORMING PROCESS, WHICH LED TO AN INCREASE IN BLADE INTERFERENCE AND ROUGH ACTUATION. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE INSPECTION ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED JANUARY 30TH, 2018 FROM A SALES REP: THE TROUBLE WAS NOTICED IN SITU. A SECOND SCISSOR WAS TRIED, AFTER THAT THE LOT WAS SET ASIDE.

    Additional Manufacturer Narrative · 1

    APPLIED MEDICAL HAS JUST RECEIVED THE EVENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: HEMICOLECTOMY. EVENT DESCRIPTION: STIFF / BROKEN LOCKING MECHANISM (DIFFICULT TO CLOSE). DESCRIPTION FROM CER FORM RECEIVED FROM REP BY EMAIL ON NOVEMBER 28, 2017: "EINE CB030 SCHERE WURDE WÄHREND EINER HEMIKOLEKTOMIE STERIL ANGEREICHT UND WÄHREND DER NUTZUNG SEI DIESE SEHR SCHWERFÄLLIG ZU SCHLIESSEN GEWESEN (IM VERGLEICH GROSSER KRAFTAUFWAND NÖTIG). DER SCHERENKOPF SCHIEN VERZOGEN ZU SEIN BZW. DIE SCHNEIDEN ZU ENG ANEINANDER ZU VERLAUFEN. DA DER KUNDE IN DEN LETZTEN 12 MONATEN 860 SCHEREN BEZOGEN HAT, WURDE DIES ALS UNGEWÖHNLICHER ZUSTAND / DEFEKT WAHRGENOMMEN, DA DERARTIGE STÖRUNGEN NIE AUFGETRETEN SIND. INSGESAMT WURDE AUS EINER CB030 BOX MIT 10 SCHEREN UND MIT O.G. LOT# 1 SCHERE STÖRUNGSFREI GENUTZT, 1 WEITERE SCHERE WAR EBENFALLS DEFEKT. ALLE VERBLEIBENDEN 7 SCHEREN WURDEN VON DER OP-SCHWESTER JULIANE AUS SORGE VOR WEITEREN STÖRUNGEN AUS DEM VERKEHR GEZOGEN." TRANSLATION AME: A CB030 SCISSOR WAS HANDED OVER STERILE DURING A HEMICOLECTOMY, AND WHILE USING IT THEY WERE VERY DIFFICULT TO CLOSE (A LOT OF FORCE NEEDED IN COMPARISON). THE HEAD OF THE SCISSORS SEEMED TO BE WARPED OR RATHER THAT THE BLADES RAN TOO CLOSE TO EACH OTHER. SINCE THE CUSTOMER HAS ORDERED 860 SCISSORS IN THE PAST 12 MONTHS, THIS WAS PERCEIVED AS UNUSUAL / FAULTY, BECAUSE SIMILAR INCIDENTS HAVE NEVER HAPPENED. IN TOTAL, FROM A BOX WITH 10 SCISSORS OF THIS LOT, 1 WAS USED WITHOUT INCIDENT, 1 OTHER WAS ALSO FAULTY (NOTE AME: CER 2017-2242). THE REMAINING 7 SCISSORS WERE SET ASIDE BY THE OR NURSE FOR FEAR OF FURTHER MALFUNCTIONS. TYPE OF INTERVENTION: N/A. PATIENT STATUS: DID A PATIENT INJURY OR ILLNESS OCCUR ASSOCIATED WITH THE COMPLAINT EVENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9488 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX HET HET APPLIED MEDICAL RESOURCES CB030 1300926 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1