BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 2862524 · Received December 10, 2012

    Report

    Report Number
    3005075853-2012-05515
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BOWEL RESECTION PROCEDURE, THE STAPLE LINE WAS INSPECTED AND THE SURGEON DID NOT LIKE THE WAY IT LOOKED, DIDN'T LOOK COMPLETE. OVER SEWED ANASTOMOSIS TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM ENDOSCOPE AND/OR ACCESSORIES KOG ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1