BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7695869 · Received July 17, 2018

    Report

    Report Number
    2210968-2018-74453
    Event Type
    Injury
    Date Received
    July 17, 2018
    Report Date
    June 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: CELL BIOCHEM BIOPHYS. 2014; 68: 541 546. DOI: 10.1007/S12013-013-9735-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: ENCLOSED PASSIVE INFRAVERSION LAVAGE¿DRAINAGE SYSTEM (EPILDS): A NOVEL SAFE TECHNIQUE FOR LOCAL MANAGEMENT OF EARLY STAGE BILE LEAKAGE AND PANCREATIC FISTULA POST PANCREATODUODENECTOMY" AUTHORS: KAI JIANG, WENZHI ZHANG, YUQUAN FENG, MING SU, JIAHONG DONG, ZHIQIANG HUANG CITATION: CELL BIOCHEM BIOPHYS. 2014; 68: 541 546. DOI: 10.1007/S12013-013-9735-0. THIS STUDY¿S OBJECTIVE WAS TO TEST THE NEW DRAINAGE APPARATUS CALLED ENCLOSED PASSIVE INFRAVERSION LAVAGE¿DRAINAGE SYSTEM (EPILDS) IN THE TREATMENT OF BILE LEAKAGE AND PANCREATIC FISTULA POST PANCREATICODUODENECTOMY (PD). THE PATIENTS INVOLVED PATIENT 2, A (B)(6) MALE PATIENT WHO EXPERIENCED CLASSICAL PD DUE TO CANCER. DURING THE SURGICAL PROCEDURE, THE FULL THICKNESS OF THE PANCREATICO-JEJUNAL END SIDE WAS INTERRUPTED AND SUTURED WITH MERSILK 3-0 NON-ABSORBABLE SUTURE. A CONTINUOUS FULL THICKNESS SUTURE WAS APPLIED USING MONOCRYL 4¿0 SYNTHETIC ABSORBABLE SUTURE. IN PATIENT 2, REPORTED COMPLICATIONS INCLUDED DARK-YELLOW LIQUID WAS IN THE DRAINAGE TUBE, GRADE B BILE LEAKAGE, AND GRADE C FISTULA. AN EXPLORATORY OPERATION WAS NEEDED AND BOTH PATIENTS RECEIVED THERAPY WITH EPILDS FOR 10 CONSECUTIVE DAYS, STARTING, RESPECTIVELY, ON POST-OPERATIVE DAY 5 AND DAY 7. THE DRAINAGE PROCESS WAS STOPPED WHEN BOTH CONCENTRATIONS APPROACHED NORMAL RANGES OR BECAME NORMAL, AND THE TEMPERATURE WAS NORMAL. IT WAS CONCLUDED THAT THE EPILDS HAS A SIMPLE AND PRACTICAL DESIGN. IT CHANGES THE ACTIVE WASHING PROCESS INTO A PASSIVE ONE, IN WHICH THE INPUT IS CONTROLLED BY THE EXITING FLUID. THIS IS THE EFFECTIVE AND SAFE SYSTEM FOR TREATMENT OF SEVERE BILE LEAKAGE AND PANCREATIC FISTULA AT THE EARLY POST-OPERATIVE STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535037 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention