BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOLOOP* LIGATURE

    MDR report key: 2884577 · Received December 23, 2012

    Report

    Report Number
    2210968-2012-08364
    Event Type
    Malfunction
    Date Received
    December 23, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 2, 2012
    Manufacturer
    ETHICON, INC
    Product Code
    GAN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE CONCERNED SAMPLE SHOWS A CRACKED MECANYL TUBE WITH AN ALMOST CLOSED TWISTED LOOP. THE SUTURE WAS CURLED RIGHT BEHIND THE CANULA. THE VISUAL INSPECTION OF THE KNOT SHOWS THAT HE WAS CONFIGURED CORRECTLY. THE CAUSE FOR TWISTING OF THE LOOP AND THE CURLING AFTER THE CANULA COULD NOT BE VERIFIED. IT SEEMS TO HAVE OCCURED DURING CLOSING OF THE LOOP BY THE CUSTOMER. NO BREAKAGE COULD BE VERIFIED. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC APPENDECTOMY ON (B)(6) 2012 AND SUTURE WAS USED. THE LIGATION LOOP BROKE WHEN APPROACHING THE TARGET TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOLOOP* LIGATURE SUTURE ABSORBABLE GAN ETHICON, INC NA EES055

    Patients

    Seq Age Sex Outcome Treatment
    1