BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSUTURE SUTURE ASSISTANT

    MDR report key: 3994296 · Received August 8, 2014

    Report

    Report Number
    3005075853-2014-05564
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K972679
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION WAS NOT PROVIDED BY THE CONTACT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DESCRIBE THIS SURGEON¿S TYPICAL USE OF THE DEVICE? DOES THE SURGEON PROVIDE TRACTION ON THE SUTURE WHILE FIRING THE DEVICE? IS IT COMPLETED 90 DEGREES TO THE DEVICE OR UP? WHAT ANGEL IS THE TRACTION AS COMPARED TO THE DEVICE SHAFT? DOES THE SURGEON FIRE THE DEVICE IN A ONE THUMB STROKE OR SLOW MULTIPLE STROKES. WAS THE INSTRUMENT HOLE (WITH SUTURE LOOP) DIRECTLY FACING THE VESSEL? HOW MANY KNOTS WERE PLACED? WERE THERE ANY ISSUES WITH KNOT DEPLOYMENT IN THE ORIGINAL PROCEDURE? WERE THERE ANY ISSUES LOADING OR UNLOADING THE CARTRIDGE? WHAT PRODUCT IS BEING RETURNED? DID THE SURGEON SAVE THE USED CARTRIDGES OR THE DEVICE AFTER THE ORIGINAL PROCEDURE? IF SO, FOR WHAT REASON? TWO CARTRIDGES WERE RETURNED INSIDE ITS STERILE AND CLOSED PACKAGE. THE CARTRIDGES WERE VISUALLY INSPECTED AND NO ANOMALIES WERE NOTED. A SW100 TEST DEVICE WAS USED TO EVALUATE THE SUTURE; UPON FUNCTIONAL TESTING THE SUTURE WAS LOADED WITHOUT ANY DIFFICULTIES AND THE KNOT FORMED AS INTENDED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON PROVIDE TRACTION ON THE SUTURE WHILE FIRING THE DEVICE? YES, SUTURE WAS UNDER MODERATE AND APPROPRIATE TENSION DURING KNOT PLACEMENT. IS IT COMPLETED 90 DEGREES TO THE DEVICE OR UP? WHAT ANGEL IS THE TRACTION AS COMPARED TO THE DEVICE SHAFT? 90°. DOES THE SURGEON FIRE THE DEVICE IN A ONE THUMB STROKE OR SLOW MULTIPLE STROKES. IN ONE STROKE. WERE THERE ANY ISSUES WITH KNOT DEPLOYMENT IN THE ORIGINAL PROCEDURE? NO ISSUES NOTICED DURING INITIAL PROCEDURE. WERE THERE ANY ISSUES LOADING OR UNLOADING THE CARTRIDGE? THERE WERE NO ISSUES DURING LOADING AND UNLOADING OF THE CARTRIDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FUNDOPLICATION PROCEDURE, THE FIRST USE WAS IN (B)(6) 2014, NOW THE SURGEON HAD TO RE-OPERATE ON THE PATIENT, SUTURE WASN'T FIXED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467421 ENDOSUTURE SUTURE ASSISTANT LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA L4EG7K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SW110