BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX

    MDR report key: 13698497 · Received March 8, 2022

    Report

    Report Number
    2027111-2022-00452
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    January 25, 2022
    Report Date
    April 22, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    UDI-DI
    00607915125318
    PMA / PMN Number
    K011236
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. HOWEVER, A PHOTO WAS PROVIDED, CONFIRMING THE COMPLAINANT'S EXPERIENCE OF CLIP SLIPPAGE. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE CLIP SLIPPAGE WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCTS AND IS UNABLE TO DETERMINE THE CAUSE OF THE CLIP SLIPPAGE. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY WITH INTRAOPERATIVE CHOLANGIOGRAPHY EVENT DESCRIPTION: [TRANSLATION] WE EXPERIENCED AN ISSUE WITH THE EPIX CLIP APPLIER ON (B)(6) 2022, AND WOULD LIKE TO FILE AN INCIDENT REPORT. PATIENT CONDITION: FAIRLY ABUNDANT BLOODY EFFUSION (500CC ASPIRATION) AFTER CHOLECYSTECTOMY. CORRECTIVE MEASURES: INSTALLATION OF CLIPS FROM ANOTHER BRAND TO CLIP AGAIN TIME OF THE EVENT: PLACEMENT OF CLIPS ON THE CYSTIC ARTERY WITHOUT PROBLEM THEN SECTION OF THE CANAL AND THE CYSTIC ARTERY. REALIZATION OF THE CHOLECYSTECTOMY, THEN APPEARANCE OF A BLOODY EFFUSION: AFTER ASPIRATION THERE IS NO LONGER ANY CLIP ON THE CYSTIC DUCT. THESE ELEMENTS ARE INCLUDED IN THE PATIENT'S OPERATIVE REPORT. [ORIGINAL] NOUS AVONS RENCONTRÉ UN PROBLÈME AVEC LA PINCE À CLIPS EPIX LE (B)(6), ET NOUS SOUHAITONS FAIRE UNE DÉCLARATION D¿INCIDENT. ETAT PATIENT : ÉPANCHEMENT SANGLANT ASSEZ ABONDANT (ASPIRATION DE 500CC) APRÈS LA CHOLÉCYSTECTOMIE MESURES CORRECTIVES : POSE DE CLIPS D¿UNE AUTRE MARQUE POUR CLIPPER À NOUVEAU MOMENT DE L¿ÉVÈNEMENT : POSE DE CLIPS SUR L¿ARTÈRE CYSTIQUE SANS PROBLÈME PUIS SECTION DU CANAL ET DE L¿ARTÈRE CYSTIQUE. RÉALISATION DE LA CHOLÉCYSTECTOMIE, PUIS APPARITION D¿UN ÉPANCHEMENT SANGLANT : APRÈS ASPIRATION IL N¿Y A PLUS DE CLIP SUR LE CANAL CYSTIQUE. CES ÉLÉMENTS FIGURENT DANS LE COMPTE-RENDU OPÉRATOIRE DU PATIENT. VOUS REMERCIANT PAR AVANCE DE REVENIR VERS NOUS POUR NOUS INDIQUER SI VOUS AVEZ CONNAISSANCE DE CE TYPE DE PROBLÈME. INTERVENTION: INSTALLATION OF CLIPS FROM ANOTHER BRAND TO CLIP AGAIN. PATIENT STATUS: FAIRLY ABUNDANT BLOODY EFFUSION (500CC ASPIRATION) AFTER CHOLECYSTECTOMY.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY WITH INTRAOPERATIVE CHOLANGIOGRAPHY. EVENT DESCRIPTION: TRANSLATION: WE EXPERIENCED AN ISSUE WITH THE EPIX CLIP APPLIER ON (B)(6) 2022, AND WOULD LIKE TO FILE AN INCIDENT REPORT. PATIENT CONDITION: FAIRLY ABUNDANT BLOODY EFFUSION (500CC ASPIRATION) AFTER CHOLECYSTECTOMY. CORRECTIVE MEASURES: INSTALLATION OF CLIPS FROM ANOTHER BRAND TO CLIP AGAIN TIME OF THE EVENT: PLACEMENT OF CLIPS ON THE CYSTIC ARTERY WITHOUT PROBLEM THEN SECTION OF THE CANAL AND THE CYSTIC ARTERY. REALIZATION OF THE CHOLECYSTECTOMY, THEN APPEARANCE OF A BLOODY EFFUSION: AFTER ASPIRATION THERE IS NO LONGER ANY CLIP ON THE CYSTIC DUCT. THESE ELEMENTS ARE INCLUDED IN THE PATIENT'S OPERATIVE REPORT. THANKING YOU IN ADVANCE FOR COMING BACK TO US TO LET US KNOW IF YOU ARE AWARE OF THIS TYPE OF PROBLEM. ORIGINAL: NOUS AVONS RENCONTRÉ UN PROBLÈME AVEC LA PINCE À CLIPS EPIX LE 25 JANVIER 2022, ET NOUS SOUHAITONS FAIRE UNE DÉCLARATION D¿INCIDENT. ETAT PATIENT : ÉPANCHEMENT SANGLANT ASSEZ ABONDANT (ASPIRATION DE 500CC) APRÈS LA CHOLÉCYSTECTOMIE MESURES CORRECTIVES : POSE DE CLIPS D¿UNE AUTRE MARQUE POUR CLIPPER À NOUVEAU MOMENT DE L¿ÉVÈNEMENT : POSE DE CLIPS SUR L¿ARTÈRE CYSTIQUE SANS PROBLÈME PUIS SECTION DU CANAL ET DE L¿ARTÈRE CYSTIQUE. RÉALISATION DE LA CHOLÉCYSTECTOMIE, PUIS APPARITION D¿UN ÉPANCHEMENT SANGLANT : APRÈS ASPIRATION IL N¿Y A PLUS DE CLIP SUR LE CANAL CYSTIQUE. CES ÉLÉMENTS FIGURENT DANS LE COMPTE-RENDU OPÉRATOIRE DU PATIENT. VOUS REMERCIANT PAR AVANCE DE REVENIR VERS NOUS POUR NOUS INDIQUER SI VOUS AVEZ CONNAISSANCE DE CE TYPE DE PROBLÈME. INTERVENTION: INSTALLATION OF CLIPS FROM ANOTHER BRAND TO CLIP AGAIN. PATIENT STATUS: FAIRLY ABUNDANT BLOODY EFFUSION (500CC ASPIRATION) AFTER CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2633280 CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX CLIP, IMPLANTABLE FZP APPLIED MEDICAL RESOURCES CA500 1417521 00607915125318

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose