BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR URETERAL ACCESS SHEATH AND DILATORS

    MDR report key: 7757486 · Received August 7, 2018

    Report

    Report Number
    1820334-2018-02437
    Event Type
    Malfunction
    Date Received
    August 7, 2018
    Date of Event
    July 23, 2018
    Report Date
    August 23, 2018
    Manufacturer
    COOK INC
    Product Code
    KOE
    UDI-DI
    00827002461680
    PMA / PMN Number
    K961904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: SEMI-RIGID AND FLEXIBLE SCOPES, MOTION HYBRID WIRE GUIDE. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, AND QUALITY CONTROL DATA. ONE OPENED PACKAGE LABELED RPN FUS-140045 WITH LABEL LOT NUMBER 8010615 WAS RECEIVED. ONLY THE SHEATH WAS RETURNED. THE DILATOR WAS NOT RETURNED. A VISUAL EXAMINATION OF THE DISTAL TIP REVEALED THE EDGE HAD A RAGGED APPEARANCE. UNDER MAGNIFICATION SCRAPE MARKS WERE OBSERVED ON THE SIDEWALL NEAR THE TIP. A SECTION OF THE INNER LINING HAS BEEN SCRAPED OFF EXPOSING SOME OF THE COILS; THIS SECTION OF LINING WAS NOT RETURNED. THE REMAINING LINING HAS PULLED AWAY FROM THE SHEATH'S SIDEWALL. SHEATH WAS LIKELY DAMAGED WHEN INTRODUCING INSTRUMENT(S) AND SCRAPING THE SIDEWALL DURING TRANSITION. A REVIEW OF THE DEVICE HISTORY RECORD NOTED THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A SEARCH OF COMPLAINT RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH COMPLAINT LOT NUMBER 8010615. THE DOCUMENT REVIEW AND DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY MANUFACTURING OR PROCESS ANOMALIES WITH THE DEVICE. THE RETURNED DEVICE CONFIRMED THE CUSTOMER¿S COMPLAINT. BASED ON THE RETURNED DEVICE SHOWING INDICATIONS OF BEING SCRAPED IT IS POSSIBLE THAT PROCEDURAL AND CLINICAL FACTORS HAVE IMPACTED THIS EVENT AS REPORTED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS USING THE FLEXOR URETERAL ACCESS SHEATH WITH THE SCOPE, AND THE INNER ¿LINER¿ FROM THE OUTSIDE SHEATH PEELED AWAY. CASE WAS COMPLETED AS NORMAL. ADDITIONAL INFORMATION WAS PROVIDED DURING FOLLOW UP. THE SHEATH WAS TAKEN OUT OF THE PATIENT AND THE STENT WAS PLACED. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Description of Event or Problem · 1

    NO NEW INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED ON 07AUG2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597861 FLEXOR URETERAL ACCESS SHEATH AND DILATORS KOE DILATOR, URETHRAL KOE COOK INC 8010615 00827002461680

    Patients

    Seq Age Sex Outcome Treatment
    1