BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW IMP FENES GRSP FRCP JAW IN

    MDR report key: 7550296 · Received May 29, 2018

    Report

    Report Number
    1320894-2018-00130
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    May 4, 2018
    Report Date
    June 26, 2018
    Manufacturer
    AB MEDICA SAS
    Product Code
    GCJ
    PMA / PMN Number
    K140101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS BEING RETURNED TO PRIVATE LABEL MANUFACTURER FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS VISUALLY INSPECTED BY A CONMED LAB TECHNICIAN. INSPECTION FOUND THAT THE GRASPER JAWS WERE BENT AWAY FROM EACH OTHER. THE DEVICE WAS TRANSFERRED TO THE ORIGINAL MANUFACTURER FOR FURTHER EVALUATION. THIS EVALUATION HAS NOT BEEN RECEIVED TO DATE. REQUEST FOR THE EVALUATION HAVE BEEN SENT TO THE MANUFACTURER. SHOULD THE EVALUATION BE RECEIVED A FOLLOW UP REPORT WILL BE FILED. OTHERWISE THIS FILING WILL STAND AS THE FINAL REPORT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF ONE COMPLAINT, REGARDING THIS ONE DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 324 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. THE REPORTED RATE OF FAILURE FOR THIS DEVICE AND FAILURE MODE IS 0.003. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: CAUTIONS: PRIOR TO EACH USE, INSPECT THE PRODUCT FOR LOOSE, BENT, BROKEN, CRACKED, WORN OR FRACTURED COMPONENTS. DO NOT USE THE PRODUCT IF IT IS DAMAGED OR DEFECTIVE. TO AVOID DAMAGE TO THE WORKING END: CAREFULLY INSERT THE DEVICE THROUGH THE WORKING CHANNEL.

    Description of Event or Problem · 1

    THIS DISTRIBUTOR REPORTED THAT THE C-LIL-IP-FS-31, LOW IMP FENES GRSP FRCP JAW IN, BROKE DURING THE REMOVAL OF THE STONE FROM THE GALLBLADDER. THIS TOOK PLACE ON (B)(6) 2018 DURING A LAP CHOLECYSTECTOMY PROCEDURE AND CAUSED A 15-MINUTE DELAY. IT IS REPORTED THAT NO COMPONENT OF THE DEVICE CAME LOOSE AND INTO CONTACT WITH THE PATIENT; THEREFORE, NO COMPONENTS WERE REQUIRED TO BE RETRIEVED. THE PATIENT IS REPORTED TO HAVE NOT SUSTAINED ANY INJURY DUE TO THIS EVENT; NEITHER DID THE PATIENT HAVE ANY TYPE OF EXTENDED STAY IN THE HOSPITAL. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390387 LOW IMP FENES GRSP FRCP JAW IN LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS 170626-4

    Patients

    Seq Age Sex Outcome Treatment
    1