BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CTR73, 12X100 KII Z-THR OPT, 6/BX

    MDR report key: 7142411 · Received December 22, 2017

    Report

    Report Number
    2027111-2017-02165
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 30, 2017
    Report Date
    March 8, 2018
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915123680
    PMA / PMN Number
    K060096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. HOWEVER, A PHOTOGRAPH OF THE EVENT UNIT WAS PROVIDED BY THE COMPLAINANT, WHICH CONFIRMED THE COMPLAINANT'S EXPERIENCE OF A FRACTURED CANNULA. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS. THIS REPORT REPRESENTS THE INITIAL AND FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE CANNULA OF THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT'S EXPERIENCE OF A FRACTURED CANNULA. BASED ON THE CONDITION OF THE RETURNED UNIT AND THE DESCRIPTION OF THE EVENT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY UNEVEN WALL THICKNESS, WHICH OCCURRED DURING THE INJECTION MOLDING PROCESS OF THE CANNULA. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE MODE 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 HAS IMPLEMENTED PROCESS ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO OCCUR.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LUNG RESECTION PROCEDURE EVENT DESCRIPTION: ITALIAN DESCRIPTION OF THE EVENT: IL DR. [] E LA DR.SSA [], CHIRURGIA TORACICA, UTILIZZANO I NOSTRI TROCAR AL POSTO DEI TROCAR TORACICI DA DIVERSI ANNI. IL 30 NOVEMBRE 2017 HANNO EFFETTUATO UN INTERVENTO DI RESEZIONE DI UN NODULO DELLA LINGULA SINISTRA POLMONARE IN VATS, UTILIZZANDO TRE TROCAR. UN TROCAR CTR73 E 2 CANNULE CTS22. NEL CTR73, POSIZIONATO POSTERIORMENTE INTORNO TRA IL 6º E IL 7º SPAZIO INTERCOSTALE. HANNO INSERITO L`OTTICA DA 10MM, I CTS22 ERA I TROCAR OPERATIVI. IL PROBLEMA É CAPITATO SUL PRIMO TROCAR INSERITO, QUELLO DELL`OTTICA. IL CHIRURGO CHE TENEVA L'OTTICA RIFERISCE DI NON AVER EFFETTUATO MOVIMENTI BRUSCHI O DI LEVA SUL TROCAR CON L`OTTICA. L`OTTICA ERA POSIZIONATA SOPRA IL CAMPO ED É RIMASTA PER LO PIU FERMA. ALLA FINA DELL`INTERVENTO, DURANTE IL LAVAGGIO, HANNO NOTATO UN PEZZO DI PLASTICA SOPRA IL LOBO INFERIRE DI SINISTRA DEL POLMONE. LA PARTE TERMINALE DEL TROCAR SI ERA SPEZZATA ED ERA CADUTA. É LA PRIMA VOLTA CHE CAPITA UN FATTO SIMILE, ED IL CLIENTE NON INTENDE FARE UNA SEGNALAZIONE AL MINISTERO, CONSIDERANDO ANCHE CHE, PER FORTUNA, IL PAZIENTE NON HA SUBITO DANNI, MA CHIEDE RISPOSTE CELERI IN MERITO AL PROBLEMA. ENGLISH TRANSLATION: DR. (B)(6), THORACIC SURGICAL DEPARTMENT, USE OUR TROCARS INSTEAD OF THORACIC TROCARS SINCE SEVERAL YEARS. ON B)(6) 2017 THEY PERFORMED A RESECTION OF A NODULE OF THE LEFT PULMONARY LINGULA IN VATS, USING THREE TROCARS. ONE CTR73 AND 2 CANNULAS CTS22. IN THE CTR73, PLACED AT THE BACK BETWEEN THE 6TH AND 7TH INTERCOSTAL SPACE, THEY INSERTED THE 10 MM SCOPE, THE CTS22 WERE THE SURGICAL TROCARS. THE ISSUE WAS NOTICED ONLY IN THE TROCAR WHERE THE SCOPE WAS INSERTED. THE SURGEON WHO WAS HOLDING THE SCOPE MENTIONED THAT HE DID NOT DO ANY SHARP OR LEVER MOVEMENT ON THE TROCAR. THE SCOPE WAS PLACED ABOVE AND IT REMAINED STILL, MOST OF THE TIME. AT THE END OF THE SURGERY, DURING THE IRRIGATION, THEY NOTICED A PIECE OF PLASTIC ON TOP OF THE LOWER LEFT LOBE OF THE LUNG. THE DISTAL PART OF THE TROCAR BROKE AND IT FELL. THIS IS THE FIRST TIME THAT A SIMILAR EVENT HAPPENED AND THE CUSTOMER IS NOT GOING TO INFORM THE MINISTRY OF HEALTH, CONSIDERING ALSO THAT FORTUNATELY THE PATIENT DID NOT GET ANY INJURY, BUT HE'S ASKING A PROMPT FEEDBACK REGARDING THIS ISSUE. ADDITIONAL INFORMATION RECEIVED FROM SALES REPRESENTATIVE VIA TELEPHONE ON 21 DEC 2017: CUSTOMER INFORMED ME THAT INCIDENT HAS BEEN REPORTED TO THE MINISTRY OF HEALTH BECAUSE AFTER DISCUSSING THE EVENT WITHIN THE HOSPITAL THEY DECIDED TO REPORT IT. HOWEVER CUSTOMER MENTIONED 2 MODEL NUMBERS IN THEIR REPORT, ALSO THIS HAS BEEN CLARIFIED. MODEL NUMBER INVOLVED IT'S ONLY CTR73, CONFIRMED ALSO BY SURGEON DR. (B)(6). 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
    923429 CTR73, 12X100 KII Z-THR OPT, 6/BX GCJ GCJ APPLIED MEDICAL RESOURCES CTR73 1278557 00607915123680

    Patients

    Seq Age Sex Outcome Treatment
    1