BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 8718889 · Received June 20, 2019

    Report

    Report Number
    2210968-2019-83063
    Event Type
    Injury
    Date Received
    June 20, 2019
    Report Date
    May 27, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (VICRYL SUTURE) 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 PRODUCT (VICRYL SUTURE) USED IN THIS PROCEDURE? CITATION: ASIAN JOURNAL OF SURGERY. 2015; 38: 214E219. DOI: HTTP://DX.DOI.ORG/10.1016/J.ASJSUR.2014.09.004. SEE REFERENCED ARTICLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : SHORT- AND LONG-TERM RESULTS OF HARMONIC SCALPEL HEMORRHOIDECTOMY VERSUS STAPLER HEMORRHOIDOPEXY IN TREATMENT OF HEMORRHOIDAL DISEASE. " AUTHOR : YUSUF BILGIN, SEMIH HOT*, _ILHAMI SOYKAN BARLAS, ARZU AKAN, YAVUZ ERYAVUZ. CITATION: ASIAN JOURNAL OF SURGERY. 2015; 38: 214E219. DOI: HTTP://DX.DOI.ORG/10.1016/J.ASJSUR.2014.09.004. IN THIS PROSPECTIVE RANDOMIZED STUDY, THE AIM IS TO COMPARE THE SHORT AND LONG-TERM RESULTS OF HARMONIC SCALPEL HEMORRHOIDECTOMY (HSH) AND STAPLER HEMORRHOIDOPEXY (SH) METHODS IN THE SURGICAL TREATMENT OF GRADE III AND GRADE IV HEMORRHOIDAL DISEASE. A TOTAL OF 99 CONSECUTIVE PATIENTS DIAGNOSED WITH GRADE III OR GRADE IV INTERNAL HEMORRHOIDAL DISEASE WERE INCLUDED IN THE STUDY. PATIENTS WERE RANDOMIZED TO HSH (N-48; MEAN AGE: 44.9 YEARS; 28 MALE AND 20 FEMALE PATIENTS) OR SH (N-51; MEAN AGE: 44.3 YEARS; 32 MALE AND 19 FEMALE PATIENTS) TREATMENTS. DURING THE SURGICAL PROCEDURE IN THE HSH GROUP, HARMONIC SCALPEL (ETHICON) SEALS BLEEDING VESSELS AND FORMS PROTEIN COAGULUM. WHEN USED IN HEMORRHOIDECTOMY, THIS METHOD MINIMIZES BLEEDING OF LARGE HEMORRHOIDS AND DECREASES OPERATIVE TIME. IT WAS REPORTED THAT SUTURES WERE NOT USED. DURING THE SURGICAL PROCEDURE IN THE SH GROUP, PPH01 KIT (ETHICON), A PURSE-STRING SUTURE ANOSCOPE (PSA), A SUTURE THREADER, AND A 33-MM HEMORRHOIDAL CIRCULAR STAPLER, WAS USED. THE PURSESTRING WAS DONE BETWEEN 3 CM AND 4 CM ABOVE THE DENTATE LINE; THE PURSE-STRING WAS COMPLETED WITH SIX TO EIGHT STITCHES, WHICH INCLUDED ONLY THE MUCOSAL AND SUBMUCOSAL LAYERS, AND HEMOSTATIC STITCHES USING A VICRYL 3-0 (ETHICON) SUTURE ON A ROUND BODY WERE USED IN CASE OF BLEEDING. IN THE HSH GROUP, REPORTED SHORT-TERM COMPLICATION INCLUDED BLEEDING (N-5); REPORTED LONG-TERM COMPLICATION INCLUDED RECURRENCE (N-1). IN THE SH GROUP, REPORTED SHORT-TERM COMPLICATIONS INCLUDED POST-OPERATIVE PAIN (N-37), WOUND PROBLEMS (N-8), AND BLEEDING (N-8); REPORTED LONG-TERM COMPLICATIONS INCLUDED RECURRENCE (N-7) AND PERIANAL FISTULA (N-1). IT WAS CONCLUDED THAT THE HSH AND SH ARE BOTH SAFE AND EFFECTIVE METHODS FOR SURGICAL TREATMENT OF GRADE III AND GRADE IV HEMORRHOIDAL DISEASE. IN THE STUDY, THE HSH METHOD WAS DETERMINED TO BE SAFER, EASIER, AND FASTER TO PERFORM, AND ASSOCIATED WITH FEWER LONG-TERM RECURRENCES THAN THE SH METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512292 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention