BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7346504 · Received March 16, 2018

    Report

    Report Number
    2210968-2018-71504
    Event Type
    Injury
    Date Received
    March 16, 2018
    Report Date
    March 1, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? DOES THE SURGEON BELIEVE THAT ANY DEFICIENCY WITH THE ETHICON PRODUCT VICRYL SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, HEMORRHAGE, PARAESOPHAGEAL FISTULA? WHAT MEDICAL/ SURGICAL INTERVENTION WAS PERFORMED TO TREAT THE PARAESOPHAGEAL FISTULA? THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: EUR ARCH OTORHINOLARYNGOL (2014) 271:765¿770; DOI 10.1007/S00405-013-2579-9; PUBLISHED ONLINE: 6 JUNE 2013 PLEASE SEE ATTACHED REFERENCE ARTICLE. - ATTACHMENT: [PC-138620- ANAGIOTOS 2013 (1).PDF]

    Description of Event or Problem · 1

    TITLE: ENDOSCOPIC LASER-ASSISTED DIVERTICULOTOMY WITHOUT VERSUS WITH WOUND CLOSURE IN THE TREATMENT OF ZENKER¿S DIVERTICULUM. THE AIM OF THIS RETROSPECTIVE REVIEW WAS TO COMPARE THE MODIFICATIONS OF ENDOSCOPIC LASER-ASSISTED DIVERTICULOTOMY REGARDING CLOSURE OF MUCOSAL WOUND AT THE CRICOPHARYNGEAL BRIDGE. BETWEEN THE YEARS OF 1983 AND 2011, DATA OF 62 PATIENT CASES THAT UNDERWENT ENDOSCOPIC LASER-ASSISTED DIVERTICULOTOMY WITHOUT AND WITH WOUND CLOSURE WERE RETROSPECTIVELY COMPARED. THESE WERE DIVIDED INTO TO 2 WHERE THE MUCOSA WOUND WAS LEFT OPEN (OW) IN 35 CASES, WHEREAS A CLOSURE OF THE MUCOSA WOUND (CW) WITH SUTURES AND FIBRIN GLUE WAS PERFORMED IN 27 PATIENTS. AFTER THE LASER-ASSISTED TRANSECTION OF THE BRIDGE BETWEEN THE DIVERTICULUM SAC AND THE ESOPHAGUS, 3 ABSORBABLE SUTURES (4.0 VICRYL, ETHICON INC) WERE PLACED LATERAL ON BOTH SIDES TO CLOSE THE FREE SPACE BETWEEN THE TWO SHEETS OF MUCOSA. PARAESOPHAGEAL FISTULA (OW N=2, CW N=1) AND POST-OPERATIVE HEMORRHAGE (OW N=0, CW N=1) WERE REPORTED. A SECOND ENDOSCOPIC INTERVENTION FOR MUCOSAL WOUND CLOSURE WITH FIBRIN GLUE WAS DONE TO MANAGE POST-OPERATIVE HEMORRHAGE. IN CONCLUSION, A ROUTINE SUTURING AND SEALING IS NOT NECESSARY IN LASER-ASSISTED ENDOSCOPIC-MICROSCOPIC DIVERTICULOTOMY OF ZENKER¿S DIVERTICULUM. TREATMENT FOR THE EVENT PARAESOPHAGEAL FISTULA WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187536 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention