BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPEL-BERCI CYSTIC DUCT INTRODUCER SET

    MDR report key: 24781891 · Received April 3, 2026

    Report

    Report Number
    1820334-2026-00367
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 26, 2026
    Report Date
    May 29, 2026
    Manufacturer
    COOK INC
    Product Code
    GBZ
    UDI-DI
    00827002082977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. H3: DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. CORRECTION: H6 (ANNEX F). ADDITIONAL INFORMATION: B3 - DATE OF EVENT, B5, D4: LOT NUMBER, D4: UDI, D4: EXPIRATION DATE, D9 (DEVICE AVAILABLE FOR EVALUATION), E4. H4 (DEVICE MANUFACTURE DATE); H3. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. B3: DATE OF EVENT: EVENT DATE WAS REPORTED TO BE "LAST WEEK". E3: OCCUPATION: MATERIALS SPECIALIST. G4: PMA/510(K) #: EXEMPT. H3: DEVICE EVALUATED BY MFG?: IT IS UNKNOWN IF THE COMPLAINT DEVICE WILL BE RETURNED TO THE MANUFACTURER THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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 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

    ADDITIONAL INFORMATION WAS PROVIDED ON 09APR2026. THE CONTAMINATED DEVICE DID NOT REACH THE PATIENT. IN REGARD TO HOW THE PROCEDURE WAS COMPLETED; THERE WAS NO DELAY OR HARM. THE CUSTOMER HAD MORE ON HAND TO USE. THEY JUST COULDN'T USE THE CONTAMINATED ONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HAIR-LIKE FOREIGN MATTER WAS IDENTIFIED WITHIN THE SEALED PACKAGING OF AN APPEL-BERCI CYSTIC DUCT INTRODUCER SET. IT WAS THEN DECIDED THAT THE DEVICE WOULD NOT BE USED. NO HARM HAS CURRENTLY BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29640 APPEL-BERCI CYSTIC DUCT INTRODUCER SET GBZ; CATHETER, CHOLANGIOGRAPHY GBZ COOK INC G08297 16769680 00827002082977

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown