BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KITTNER DISSECTOR

    MDR report key: 6026633 · Received October 13, 2016

    Report

    Report Number
    2320762-2016-00022
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 13, 2016
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    GDI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY AN (B)(4) WAS RECEIVED REPORTING THAT THE TIP OF A KITTNER (FINISHED GOOD (B)(4), LOT NUMBER 41823839) DISLODGED AND WAS FOUND INSIDE THE TROCAR. THE SAMPLE WAS RECEIVED AND WILL BE SENT TO THE SUPPLIER ((B)(4)) ONCE DECONTAMINATION HAS BEEN PERFORMED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN SENT TO (B)(4), WHICH SUPPLIES THE RAW MATERIAL PRODUCT TO DEROYAL. THE WORK ORDER FOR THE FINISHED GOOD WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NONE WERE IDENTIFIED. A RAW MATERIAL INSPECTION WAS PERFORMED AND NO NON-CONFORMING PRODUCT WAS FOUND. THE COMPLAINT REPORT WAS REVIEWED FOR SALES AND SIMILAR REPORTS. (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE RAW MATERIAL IS SUPPLIED TO DEROYAL INDUSTRIES, INC. BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE (B)(4). IN ITS RESPONSE, (B)(4) STATED ITS INVESTIGATION DETERMINED SOME GLUE OPERATORS USED A SLIGHTLY VARIED METHOD OF WRAPPING TAPE ON THE END OF THE STICK. THIS VARIATION LEFT THE POTENTIAL FOR GLUE TO BE IN THE INCORRECT AREA OF THE TAPE. ADDITIONALLY, A GAP WAS IDENTIFIED IN THE TRAINING OF OPERATORS WHO HAD BEEN IN THE POSITION FOR LESS THAN 1 YEAR. CORRECTIVE ACTION: IN THE SCAR, (B)(4) HAS IDENTIFIED THE FOLLOWING CORRECTIVE ACTIONS: ADD MORE DETAILS TO THE MANUFACTURING PROCEDURE (MANUFACTURING OF ENDOKITTNER PC3060 REV. Q) TO CLARIFY THE STEPS OF THE GLUING PROCESS; RETRAIN ALL OPERATORS ON PROPER TIP FOLDING, GLUING, AND WRAPPING TECHNIQUES; AND SUPERVISOR WILL FOLLOW-UP TO ENSURE ALL OPERATORS ARE TRAINED ON THE MANUFACTURING PROCEDURE AND RELATED QUALITY DOCUMENTATION. CORRECTIONS: IN THE SCAR, (B)(4) HAS STATED PERSONNEL INVOLVED WERE NOTIFIED THROUGH WRITTEN NOTIFICATION ABOUT THE NON-CONFORMITY; INVENTORY VERIFICATION AT THE (B)(4) WAREHOUSE WAS PERFORMED AND LOTS 4K303 AND 16H3290 WILL BE REINSPECTED AT 100%; DEROYAL WILL RETURN LOTS 16F2326, 16H3290, 16D1367, AND 16B0344 TO (B)(4) FOR REINSPECTION AT 100%. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED REPORTING THAT THE TIP OF A KITTNER (FINISHED GOOD (B)(4), LOT NUMBER 41823839) DISLODGED AND WAS FOUND INSIDE THE TROCAR. THE SAMPLE WAS RECEIVED AND SENT TO THE SUPPLIER ((B)(4)) AFTER DECONTAMINATION. A SCAR WAS SENT TO (B)(4) AND A RESPONSE RECEIVED NOVEMBER 3, 2016. THE WORK ORDER FOR THE FINISHED GOOD WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NONE WERE IDENTIFIED. A RAW MATERIAL INSPECTION WAS PERFORMED AND NO NON-CONFORMING PRODUCT WAS FOUND. THE 2014-2016 SCAR AND SUPPLIER NOTIFICATION LETTER (SNL) LOGS WERE REVIEWED FOR SIMILAR COMPLAINTS. SIMILAR COMPLAINTS WERE IDENTIFIED IN 2016. THE COMPLAINT REPORT WAS REVIEWED FOR SALES AND SIMILAR REPORTS. (B)(4). NO PREVIOUS REPORTS OF THIS NATURE HAVE BEEN RECEIVED DURING THE REVIEW PERIOD. (B)(4). AS A RESULT OF THE VENDOR INVESTIGATION, DEROYAL HAS PLACED THE PRODUCT UNDER PURCHASE INSPECTION AND ASSIGNED VERIFICATION OF THE COMPLAINT. PREVENTIVE ACTION: IN THE SCAR, MEDSORB HAS STATED THE AREA SUPERVISOR WILL BE MONITORING EACH OPERATOR TO ENSURE THE GLUING PROCESS IS PERFORMED CORRECTLY. THE PRODUCTION INSPECTOR WILL CONTINUE TO CHECK ALL STICKS FOR TIP RETENTION. THE INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TIP OF THE KITTNER DISLODGED AND WAS FOUND INSIDE THE TROCAR. THE KITTNER WAS FOUND BEFORE IT WAS ABLE TO ENTER THE PATIENT. THE DEVICE WAS REPLACED WITH A NEW KITTNER.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TIP OF THE KITTNER DISLODGED AND WAS FOUND INSIDE THE TROCAR. THE KITTNER WAS FOUND BEFORE IT WAS ABLE TO ENTER THE PATIENT. THE DEVICE WAS REPLACED WITH A NEW KITTNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677885 KITTNER DISSECTOR DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY GDI MEDSORB DOMINICANA, S.A. 28-0801 41823839

    Patients

    Seq Age Sex Outcome Treatment
    1