BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7599175 · Received June 13, 2018

    Report

    Report Number
    2210968-2018-73469
    Event Type
    Injury
    Date Received
    June 13, 2018
    Report Date
    May 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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: BR J OPHTHALMOL 2012; 96: 674-678. DOI: 10.1136/BJOPHTHALMOL-2011-300860. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: A NEW LACRIMAL BYPASS TUBE FIXATION METHOD TO PREVENT TUBE DISPLACEMENT IN CONJUNCTIVODACRYOCYSTORHINOSTOMY (CDCR)" AUTHOR : MINWOOK CHANG, SEHYUN BAEK, TAE SOO LEE CITATION: BR J OPHTHALMOL 2012; 96: 674-678. DOI: 10.1136/BJOPHTHALMOL-2011-300860. THE PRINCIPAL OBJECTIVE OF THIS RETROSPECTIVE, INTERVENTIONAL AND COMPARATIVE STUDY WAS TO ASSESS THE EFFICACY OF ENDOSCOPIC CONJUNCTIVODACRYOCYSTORHINOSTOMY (CDCR) WITH THE NEW TUBE FIXATION TECHNIQUE IN ACHIEVING TUBE STABILITY. BETWEEN MAR2004 AND JAN2010, 169 PATIENTS WITH TEARING SECONDARY TO SEVERE UPPER OR LOWER CANALICULAR OBSTRUCTION UNDERWENT 174 ENDOSCOPIC CDCR WITH JONES TUBE. THE TUBE WAS FIXED USING THREE TECHNIQUES: ENCIRCLING GROUP (N=52; N=23 MALE AND N=30 FEMALE; MEAN AGE SD WAS 52.9±16.9 YEARS) WHO UTILIZED 6-0 PROLENE SUTURES, PURSE-STRING GROUP (N=51; N=26 MALE AND N=25 FEMALE; MEAN AGE SD WAS 47.7±16.0 YEARS) WHO UTILIZED 5-0 VICRYL SUTURES AND THE CONTROL GROUP (N=71; N=29 MALE AND 42 FEMALE; MEAN AGE WAS 47.3±13.7 YEARS) WHO UTILIZED 6-0 NYLON SUTURES. IN THE PURSE-STRING SUTURE PROCEDURE, 5-0 VICRYL SUTURE WAS PASSED THROUGH THE CONJUNCTIVA AND TENON¿S CAPSULE, JUST LATERAL TO THE COLLAR OF THE TUBE. THE SUTURE WAS TIED AROUND THE COLLAR OF THE TUBE IN A BURIED HORIZONTAL MATTRESS SUTURE, IN THE FASHION OF A PURSE STRING, AND EXTERNALISED TO THE SKIN OF THE MEDIAL CANTHAL REGION TO WHICH IT WAS FIXED. THE NEW TECHNIQUE OF ENCIRCLING FIXATION PROCEDURE UTILIZED 6-0 PROLENE SUTURE WHICH WAS PASSED ASSED UNDER THE DE-EPITHELIALISED AREA IN THE FASHION OF A PURSE STRING, BURYING THE SUTURE UNDER THE EPITHELIALISED CONJUNCTIVA. IN ENCIRCLING GROUP, MALPOSITION OF TUBE (N=4) WAS NOTED, AND COMPLICATIONS INCLUDED CONJUNCTIVAL GRANULOMA (N=4) AND TUBE OBSTRUCTION (N=3). IN PURSE-STRING GROUP, MALPOSITION OF TUBE (N=8) AND EXTRUSION OF TUBE (N=3) WERE NOTED, AND COMPLICATIONS INCLUDED CONJUNCTIVAL GRANULOMA (N=4), TUBE OBSTRUCTION (N=4) AND SUTURE ABSCESS (N=2). THE AUTHORS BELIEVE THAT THIS ENCIRCLING FIXATION PROCEDURE CAN HELP IN CDCRS FOR MAINTAINING THE LOCATION AND ORIENTATION OF THE TUBE DURING THE EARLY POSTOPERATIVE PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441721 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention