BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 12278422 · Received August 4, 2021

    Report

    Report Number
    2027111-2021-00592
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    July 14, 2021
    Report Date
    September 9, 2021
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    UDI-DI
    00607915110123
    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

    TEN (10) STERILE UNITS WERE RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON ALL OF THE STERILE UNITS AND ONE (1) UNIT EXHIBITED SNAGGING AT THE TIP OF THE BLADES. A SMALL GAP WAS OBSERVED BETWEEN THE TIPS OF THE BLADES. BASED ON THE EVALUATION OF THE STERILE UNIT, THE SCISSORS WERE SNAGGING DUE TO THE GAP THAT WERE OBSERVED BETWEEN THE TIPS OF THE BLADES. HOWEVER, THE EXACT ROOT CAUSE OF THE GAP COULD NOT BE DETERMINED BASED ON THE EVALUATION OF THE STERILE UNIT. 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

    NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: 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 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 ". 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". ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL COMPLAINT EVALUATION ENGINEER ON 15JUL21: PLEASE OPEN ONE NEW COMPLAINT FOR A STERILE CB030 SCISSOR UNIT THAT WAS RETURNED BY THE CUSTOMER FROM LOT 1407597. THE UNIT WAS ONE OF TEN STERILE UNITS ORIGINALLY RETURNED AS PART OF COMPLAINT (B)(4) AND FAILED SCISSOR CUT TESTING PERFORMED 14JUL2021 PER THE SCISSOR ROUGH ACTUATION AND CUT TEST. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NA.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NAME OF PROCEDURE BEING PERFORMED: NA. DETAILED DESCRIPTION OF EVENT: EVENT 1 OF 2: 2021-001351. EVENT 2 OF 2: 2021-001714. 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 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. 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 COELIOSCOPIE. 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 (B)(6). 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. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL REPRESENTATIVE ON 28JUNE21: THE PATIENT IS FINE. ADDITIONAL INFORMATION RECEIVED BY EMAIL FROM APPLIED MEDICAL COMPLAINT EVALUATION ENGINEER ON 15JUL21: PLEASE OPEN ONE NEW COMPLAINT FOR A STERILE CB030 SCISSOR UNIT THAT WAS RETURNED BY THE CUSTOMER FROM LOT 1407597. THE UNIT WAS ONE OF TEN STERILE UNITS ORIGINALLY RETURNED AS PART OF COMPLAINT (B)(4) AND FAILED SCISSOR CUT TESTING PERFORMED (B)(6) 2021 PER THE SCISSOR ROUGH ACTUATION AND CUT TEST. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT). TYPE OF INTERVENTION: NI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170271 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 1407597 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1