BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOLENDA SALIVARY ACCESS INTRODUCER SET SDAS

    MDR report key: 6493763 · Received April 14, 2017

    Report

    Report Number
    1820334-2017-00672
    Event Type
    Injury
    Date Received
    April 14, 2017
    Report Date
    May 8, 2017
    Manufacturer
    COOK INC
    Product Code
    OAJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS AND QUALITY CONTROL OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS: THE PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES. STANDARD TECHNIQUES FOR PLACEMENT OF SALIVARY ACCESS SHOULD BE EMPLOYED. WHEN INSERTING, MANIPULATING OR WITHDRAWING A DEVICE THROUGH AN INTRODUCER, ALWAYS MAINTAIN INTRODUCER POSITION. DO NOT ATTEMPT IN THE PRESENCE OR SUSPECTED PRESENCE OF UNFAVORABLE PATIENT ANATOMY. IF RESISTANCE IS ENCOUNTERED, DO NOT FORCE; DAMAGE TO THE SHEATH AND/OR DUCT MAY OCCUR. ¿THE PHYSICIAN STATED IT WAS "ONE OF THE FIRST" HE HAD DONE "WITH THE INTRODUCER." THERE IS NO INFORMATION REGARDING THE CIRCUMSTANCES THAT OCCURRED DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE PERFORATION OF THE SALIVARY DUCT. THERE IS NO INFORMATION REGARDING ANY OF THE PATIENT'S ANATOMICAL CHARACTERISTICS SUCH AS THE PERFORATION FROM AN EXISTING SALIVARY STONE. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    UNKNOWN DATE AND MONTH. YEAR OF THE EVENT: 2015. PATIENT CODE: NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT REPORTED. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING A SUBMANDIBULAR GLAND DUCT SIALOENDOSCOPY PROCEDURE ON A MALE PATIENT BY USING A KOLENDA SALIVARY ACCESS INTRODUCER SET. THE PHYSICIAN USED THE DEVICE FOR THREE TIMES, HOWEVER IT CAUSED PERFORATION OF THE SALIVARY DUCT FOR TWO TIMES. THE PHYSICIAN FURTHER STATED THAT THIS WAS ALL OF THE INFORMATION THEY WERE ABLE TO RECALL ABOUT THE EVENT. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENTS¿ BODY. THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274492 KOLENDA SALIVARY ACCESS INTRODUCER SET SDAS OAJ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1