BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGAMAX-5MM

    MDR report key: 1983716 · Received February 10, 2011

    Report

    Report Number
    3005075853-2011-00549
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 7, 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
    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)(6) 2011 WITH EES (B)(4): THE (B)(4) INDICATED THE OPERATING ROOM DIRECTOR SAID THERE HAVE BEEN NO PROCEDURAL CHANGES. THE (B)(4) REACHED OUT TO THE SURGEON WITH NO RESPONSE. THE (B)(4) WILL BE TRAVELING TO THE FACILITY TO DISCUSS THE INCIDENT: ON (B)(6) 2011 THE SALES REPRESENTATIVE MET WITH THE SURGEON TO DISCUSS THE INCIDENT. SUMMARY PROVIDED BY THE REP: "PER THE SURGEON, THE PATIENT PRESENTED WITH CHOLECYSTITIS. HE DID THE CASE AND FIRED THE DEVICE 4 TIMES, 2X ON THE PATIENT SIDE AND 2X ON THE SPECIMEN. HE SAID AGAIN THE CLIP FORMATION APPEARED "NORMAL" AND CLOSED. THEY FINISHED THE CASE AND A DRAIN WAS PLACED AT HIS DISCRETION. HE SAID THAT THE PATIENT WAS DISCHARGED, AND AT THE TIME OF DISCHARGE THERE WAS RELATIVELY NO OBVIOUS DRAINAGE. AGAIN SEVERAL DAYS LATER, THE PATIENT WAS SEEN BY THE SURGEON AND HE NOTICED "EXCESSIVE" DRAINAGE INTO HER DRAIN. HE EXPLAINED THIS INCIDENT AS "ODD" AND WOULDN'T NORMALLY EXPECT TO SEE DRAINAGE FROM A DRAIN THAT A FEW DAYS EARLIER WAS "DRY". HE TOLD THE PATIENT HE WOULD KEEP THE DRAIN IN PLACE A FEW DAYS LONGER. HE REPORTED NO FURTHER INVESTIGATION SPECIFIC TO THE CLIPS THAT WERE PLACED ON THE DUCT INTRA-OPERATIVELY. HE STATED THAT THE PATIENT IS DOING WELL AND EXPECTED 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)(6) 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. A DRAIN WAS PLACED TO TAKE CARE OF THE LEAK. THE PATIENT IS CURRENTLY UNDER HOSPITAL CARE. 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