BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 12080995 · Received June 28, 2021

    Report

    Report Number
    2027111-2021-00550
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Report Date
    August 27, 2021
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    PMA / PMN Number
    K062169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT AND (B)(4) STERILE UNITS WERE RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE EVENT UNIT AND STERILE SAMPLES; HOWEVER, ALL UNITS WERE ABLE TO CUT WITHOUT CATCHING ON TISSUE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCT AND IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE EVENT BASED ON THE EVALUATION OF THE RETURNED UNITS. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: [AME TRANSLATION]: AN ADVERSE EVENT HAS OCCURRED IN OUR ESTABLISHMENT CONCERNING THE DEVICE COELIO UU SCISSORS 5MM / 35CM - EPIX REF. CB030 BATCH NUMBER: 1407597 AND 1405605. THE MANAGER OF THE CENTRAL UNIT MRS. [NAME] DECLARES: "DURING HIS FIRST INTERVENTION, PROFESSOR [NAME] HAD TO USE 4 LAPAROSCOPY SCISSORS. THE FIRST 3 SCISSORS WITH THE BATCH NUMBERS INDICATED" CATCH "THE TISSUES. THE 4TH PAIR WAS USED. FUNCTIONAL REMOVAL OF THE SCISSORS AND PRE-DISINFECTION FOR A VISIT TO THE PHARMACY ON (B)(6). AFTER A CALL FROM MR [NAME] (APPLIED SALES REPRESENTATIVE): MATERIOVIGILANCE HAS CARRIED OUT AND REIMBURSED THESE SCISSORS POSSIBLE. LOT NUMBERS ARE 1407597 AND 1405605 ". FOLLOWING OUR TELEPHONE CONVERSATION WITH MR. [NAME], WE THEREFORE WISH TO EXCHANGE (B)(4) UNITS OF THE LOT: 1407597 AND (B)(4) UNITS OF THE LOT: 1405605. ORIGINAL: UN ÉVÈNEMENT INDÉSIRABLE EST SURVENU AU SEIN DE NOTRE ÉTABLISSEMENT CONCERNANT LE DISPOSITIF CISEAUX COELIO UU 5MM/35CM - EPIX RÉF. CB030 N° DE LOT : 1407597 ET 1405605. LE CADRE DU BLOC CENTRAL MADAME [NAME] DÉCLARE : "LORS DE SA PREMIÈRE INTERVENTION, LE PROFESSEUR [NAME] A DÛ UTILISER 4 CISEAUX DE C¿LIOSCOPIE. LES 3 PREMIERS CISEAUX AVEC LES N° DE LOTS INDIQUÉS "ACCROCHENT" LES TISSUS. LA 4ÈME PAIRE A ÉTÉ FONCTIONNELLE. RETRAIT DES CISEAUX ET PRÉ-DÉSINFECTION POUR UNE DESCENTE EN PHARMACIE CE 1ER JUIN. APRÈS APPEL DE MR [NAME] (REPRÉSENTANT COMMERCIAL APPLIED) : MATÉRIOVIGILANCE A RÉALISÉ ET REMBOURSEMENT DE CES CISEAUX POSSIBLES. LES NUMÉROS DE LOT SONT LES SUIVANTS 1407597 ET 1405605". SUITE À NOTRE CONVERSATION TÉLÉPHONIQUE AVEC MONSIEUR [NAME], NOUS SOUHAITONS DONC ÉCHANGER (B)(4) UNITÉS DU LOT : 1407597 ET (B)(4) UNITÉS DU LOT : 1405605. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 28JUNE21: INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: THE PATIENT IS FINE.

    Additional Manufacturer Narrative · 1

    THE EVENT DEVICE IS ANTICIPATED TO BE RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: NI. EVENT DESCRIPTION: [AME TRANSLATION]: AN ADVERSE EVENT HAS OCCURRED IN OUR ESTABLISHMENT CONCERNING THE DEVICE COELIO UU SCISSORS 5MM / 35CM - EPIX REF. (B)(4) BATCH NUMBER: 1407597 AND 1405605. THE MANAGER OF THE CENTRAL UNIT MRS. [NAME] DECLARES: "DURING HIS FIRST INTERVENTION, PROFESSOR [NAME] HAD TO USE 4 LAPAROSCOPY SCISSORS. THE FIRST 3 SCISSORS WITH THE BATCH NUMBERS INDICATED" CATCH "THE TISSUES. THE 4TH PAIR WAS USED. FUNCTIONAL REMOVAL OF THE SCISSORS AND PRE-DISINFECTION FOR A VISIT TO THE PHARMACY ON JUNE 1ST. AFTER A CALL FROM MR [NAME] (APPLIED SALES REPRESENTATIVE): MATERIOVIGILANCE HAS CARRIED OUT AND REIMBURSED THESE SCISSORS POSSIBLE. LOT NUMBERS ARE 1407597 AND 1405605 ". FOLLOWING OUR TELEPHONE CONVERSATION WITH MR. [NAME], WE THEREFORE WISH TO EXCHANGE 20 UNITS OF THE LOT: 1407597 AND 17 UNITS OF THE LOT: 1405605. ORIGINAL: UN ÉVÈNEMENT INDÉSIRABLE EST SURVENU AU SEIN DE NOTRE ÉTABLISSEMENT CONCERNANT LE DISPOSITIF CISEAUX COELIO UU 5MM/35CM - EPIX RÉF. (B)(4) N° DE LOT : 1407597 ET 1405605. LE CADRE DU BLOC CENTRAL MADAME [NAME] DÉCLARE : "LORS DE SA PREMIÈRE INTERVENTION, LE PROFESSEUR [NAME] A DÛ UTILISER 4 CISEAUX DE C¿LIOSCOPIE. LES 3 PREMIERS CISEAUX AVEC LES N° DE LOTS INDIQUÉS "ACCROCHENT" LES TISSUS. LA 4ÈME PAIRE A ÉTÉ FONCTIONNELLE. RETRAIT DES CISEAUX ET PRÉ-DÉSINFECTION POUR UNE DESCENTE EN PHARMACIE CE 1ER JUIN. APRÈS APPEL DE MR [NAME] (REPRÉSENTANT COMMERCIAL APPLIED) : MATÉRIOVIGILANCE A RÉALISÉ ET REMBOURSEMENT DE CES CISEAUX POSSIBLES. LES NUMÉROS DE LOT SONT LES SUIVANTS 1407597 ET 1405605". SUITE À NOTRE CONVERSATION TÉLÉPHONIQUE AVEC MONSIEUR [NAME], NOUS SOUHAITONS DONC ÉCHANGER 20 UNITÉS DU LOT : 1407597 ET 17 UNITÉS DU LOT : 1405605. INTERVENTION: CHANGE OF DEVICE. PATIENT STATUS: TO BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976698 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1