BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM

    MDR report key: 1983718 · Received February 10, 2011

    Report

    Report Number
    3005075853-2011-00550
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. CONFERENCE CALL TOOK PLACE ON (B)(4) 2011 WITH EES MARKETING, DIVISION (B)(4), CUSTOMER QUALITY, AND LIFE CYCLE ENGINEERING: THE DM INDICATED THE OR (B)(4) SAID, THERE HAVE BEEN NO PROCEDURAL CHANGES. THE DM REACHED OUT TO THE SURGEON WITH NO RESPONSE. THE DM WILL BE TRAVELING TO THE FACILITY TO DISCUSS THE INCIDENT AND TO OBTAIN THE FOLLOWING DETAILS: ON (B)(4) 2011, THE SALES REPRESENTATIVE MET WITH THE SURGEON TO DISCUSS THE INCIDENT. SUMMARY PROVIDED BY THE REP: "PER THE SURGEON, THE CLIPS APPEARED FULLY FORMED AND CLOSED ACROSS THE DUCT. HE FINISHED THE PROCEDURE AND NO COMPLICATIONS WERE NOTICED INTRAOPERATIVELY. THE SURGEON THEN STATED THAT HIS PATIENT THEN COMPLAINED OF ABDOMINAL PAIN, AND HE SCHEDULED AN ERCP. HE WITH THE GASTROENTEROLOGIST COULD SEE THE CLIPS ON THE DUCT, HOWEVER, THEY APPEARED "OPEN" AS BILE WAS COMING OUT OF THE END OF THE DUCT. HE SAID THE PATIENT IS DOING "FINE" AND IS EXPECTED TO HAVE A FULL RECOVERY. I IN- SERVICED THE SURGEON ON THE STEPS TO USE OF THE CLIP APPLIER. WE ALSO DISCUSSED THAT THE CLIP APPLIER IS NOT SUPPOSED TO HAVE THE CLIPS PRELOADED IN THE JAWS UPON INSERTION OF THE CLIP APPLIER TO THE TROCAR. THE SURGEON WILL CONTINUE TO UTILIZE THE DEVICE FOR FUTURE CASES." IN-SERVICING HAS BEEN SCHEDULED FOR THE STAFF ON (B)(4) 2011. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2-3 DAYS POST-OP A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE PATIENT HAD BILE LEAKAGE. THE PATIENT HAD AN ERCP; THAT IS WHEN THEY DISCOVERED THE CLIPS HAD OPENED. IT IS UNKNOWN HOW IT WAS CORRECTED. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention