BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    MDR report key: 9468605 · Received December 13, 2019

    Report

    Report Number
    2027111-2019-00664
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    November 18, 2019
    Report Date
    February 19, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915117382
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION WITHOUT THE TISSUE BAG. APPLIED MEDICAL IS UNABLE TO CONFIRM THAT THE PRODUCT WAS DISTRIBUTED TO THE CUSTOMER WITHOUT THE TISSUE BAG. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND THE RETURNED UNIT AND IS UNABLE TO DETERMINE THE ROOT CAUSE OF THE EVENT. 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: GALLBLADDER SURGERY. DETAILED DESCRIPTION OF EVENT: GISTEREN IS TIJDENS EEN GALBLAAS OK GECONSTATEERD DAT HET RETRIEVAL SYSTEM (ENDOCATCH 10MM), MET REF. CD001 GEEN ZAKJE AANWEZIG WAS. HET BETREFT BATCHNUMMER 1364580. HET SYSTEEM IS BEWAARD EN KAN EVENTUEEL OPGEHAALD WORDEN. TRANSLATION AME: YESTERDAY DURING A GALLBLADDER SURGERY, IT WAS NOTICED THAT THE RETRIEVAL SYSTEM (ENDOCATCH 10MM), WITH REF. CD001 DID NOT HAVE A BAG PRESENT. IT'S CONCERNING BATCH NUMBER 1364580. THE SYSTEM HAS BEEN KEPT AND CAN BE PICKED UP IF NECESSARY. ADDITIONAL INFORMATION RECEIVED FROM FITM BY EMAIL ON 22NOV2019: MOMENT OF DISCOVERY WAS INSIDE THE ABDOMEN. NO DAMAGE WAS DONE. PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE EVENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: GALLBLADDER SURGERY. GISTEREN IS TIJDENS EEN GALBLAAS OK GECONSTATEERD DAT HET RETRIEVAL SYSTEM (ENDOCATCH 10MM), MET REF. CD001 GEEN ZAKJE AANWEZIG WAS. HET BETREFT BATCHNUMMER 1364580. HET SYSTEEM IS BEWAARD EN KAN EVENTUEEL OPGEHAALD WORDEN. TRANSLATION AME: YESTERDAY DURING A GALLBLADDER SURGERY, IT WAS NOTICED THAT THE RETRIEVAL SYSTEM (ENDOCATCH 10MM), WITH REF. CD001 DID NOT HAVE A BAG PRESENT. IT'S CONCERNING BATCH NUMBER 1364580. THE SYSTEM HAS BEEN KEPT AND CAN BE PICKED UP IF NECESSARY. ADDITIONAL INFORMATION RECEIVED FROM FITM BY EMAIL ON 22NOV2019: MOMENT OF DISCOVERY WAS INSIDE THE ABDOMEN. NO DAMAGE WAS DONE. PATIENT STATUS: NO PATIENT INJURY. INTERVENTION: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262221 CD001, 10MM RETRIEVAL SYSTEM, 10/BX LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CD001 1364580 00607915117382

    Patients

    Seq Age Sex Outcome Treatment
    1