BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET

    MDR report key: 8200089 · Received December 27, 2018

    Report

    Report Number
    1820334-2018-03707
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    November 6, 2018
    Report Date
    March 1, 2019
    Manufacturer
    COOK INC
    Product Code
    GBZ
    UDI-DI
    00827002080454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION HAS PREVIOUSLY BEEN REPORTED, IS UNKNOWN OR IS UNAVAILABLE. CORRECTED DATA: DEVICE EVALUATION: THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO THE MANUFACTURER FOR INVESTIGATION. HOWEVER, A SET OF PHOTOS WERE PROVIDED FROM THE CUSTOMER AND SHOW A HAIR-LIKE FILAMENT OF FOREIGN MATTER TOWARDS THE BOTTOM OF THE PACKAGE. THE PACKAGE WAS NOT OPENED AND PRIOR TO USE, WHICH SUGGESTS THE DEVICE WAS OUT OF SPECIFICATION. INVESTIGATION: A DOCUMENT-BASED INVESTIGATION REVIEWED THE FOLLOWING: COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE, AND QUALITY CONTROL SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. PER THE IFU: ¿HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ CONCLUSION: BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE DEVICE PHOTOS, AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE WAS DETERMINED AS CAUSE TRACED TO MANUFACTURING (QUALITY CONTROL DEFICIENCY). PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. APPROPRIATE MEASURES WERE INITIATED TO ADDRESS THIS FAILURE MODE. AS A RESULT, THERE ARE NEW GOWNING PROCEDURES IN PLACE THAT SHOULD PREVENT THIS FAILURE. THE APPROPRIATE PERSONNEL WILL BE NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED FOREIGN MATTER, PIECE OF HAIR, WAS FOUND IN THE SEALED STERILE PACKAGE OF A MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET DURING INCOMING INSPECTION. THE DEVICE DID NOT MAKE PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038374 MIXTER ENDOSCOPIC CHOLANGIOGRAPHY SET GBZ CATHETER, CHOLANGIOGRAPHY GBZ COOK INC NA 8629196 00827002080454

    Patients

    Seq Age Sex Outcome Treatment
    1