BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9489892 · Received December 18, 2019

    Report

    Report Number
    2210968-2019-90922
    Event Type
    Injury
    Date Received
    December 18, 2019
    Report Date
    November 26, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION: JOURNAL ARTICLE PAGES 685-689.

    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. CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2007) 14, 682¿689; DOI:10.1016/J.JMIG.2007.05.007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE: LAPAROSCOPIC TOTAL RADICAL HYSTERECTOMY BY THE PUNE TECHNIQUE: OUR EXPERIENCE OF 248 CASES". AUTHOR(S): SHAILESH P. PUNTAMBEKAR, MS, RESHMA J. PALEP, MS, DNB, MRCS, SEEMA S. PUNTAMBEKAR, MD, GIRIJA N. WAGH, MD, ANJALI M. PATIL, MS, NEERAJ V. RAYATE, MS, DNB, AND GEETANJALI A. AGARWAL, MS. CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY (2007) 14, 682¿689; DOI:10.1016/J.JMIG.2007.05.007. THIS RETROSPECTIVE, NONRANDOMIZED STUDY AIMED TO DESCRIBE THE EXPERIENCE AND TECHNIQUE OF TOTAL LAPAROSCOPIC RADICAL HYSTERECTOMY WITH PELVIC LYMPHADENECTOMY, WHICH IS THE LARGEST SINGLE- INSTITUTION STUDY. FROM SEP2002 TO DEC2006, 248 PATIENTS WITH INTERNATIONAL FEDERATION OF GYNECOLOGY AND OBSTETRICS STAGE IA2 (N=32) AND IB1 (N=216) OF CANCER OF THE CERVIX UNDERWENT TOTAL LAPAROSCOPIC TYPE III RADICAL HYSTERECTOMY WITH BILATERAL PELVIC LYMPHADENECTOMY. IN THE PROCEDURE, HARMONIC SHEARS (ETHICON ENDO-SURGERY, INC., CINCINNATI, OH) WAS USED IN ANTERIOR AND POSTERIOR U-CUT, DISSECTION OF RECTOVAGINAL SPACE, DISSECTION OF PARARECTAL SPACE AND URETERIC TUNNERL DISSECTION. A 2-0 VICRYL (ETHICON, JOHNSON AND JOHNSON, LTD., AURANGABAD, INDIA) SUTURE ON A 30-MM NEEDLE WAS INTRODUCED THROUGH THE 10-MM WORKING PORT. THE VAGINAL CLOSURE WAS DONE ABDOMINALLY WITH CONTINUOUS INTERLOCKING SUTURES. INTRAOPERATIVE COMPLICATIONS INCLUDED BLADDER INJURY (N=3) WHICH WAS SUTURED LAPAROSCOPICALLY USING 2-0 POLYGLACTIN; HIGH URETERIC INJURY (N=1) IN WHICH THE TRANSECTED END WAS ANASTOMOSED END TO SIDE BY TAKING THE LEFT URETER TO THE NORMAL URETER ON THE OTHER SIDE WITH AN INTRACORPOREAL SUTURING TECHNIQUE; EXTERNAL ILIAC VEIN INJURY (N=1) WHICH WAS SUTURED LAPAROSCOPICALLY; UTERINE ARTERY INJURY (N=6) WHICH WAS CLIPPED OR CONTROLLED WITH LIGATURE; UTERINE VEIN INJURY (N=2) WHICH WAS CONTROLLED WITH BIPOLAR CAUTERY; AND BOWEL INJURY (N=2) WHICH WAS LAPAROSCOPICALLY SUTURED IN 2 LAYERS. EARLY POSTOPERATIVE COMPLICATIONS INCLUDED BLADDER INJURY DYSFUNCTION (N=5) REQUIRING CLEAN INTERMITTENT CATHETERIZATION WITH COMPLETE RESOLUTION WITHIN 6 MONTHS; WOUND INFECTION (N=3) TREATED WITH ANTIBIOTICS AND DRESSINGS; URETOVAGINAL FISTULA ¿ DUE TO LOW URETERIC INJURY (N=4) TREATED WITH CYSTOCCOPIC D-J STENTING IN 1 PATIENT AND LAPAROSCOPIC URETERONEOCYSTOSTOMY WITH PSOAS HITCH IN 3 PATIENTS; AND SECONDARY HEMORRHAGE (N=1) REQUIRING RELAPAROSCOPY AND PACKING. THIS TECHNIQUE OF TOTAL LAPAROSCOPIC RADICAL HYSTERECTOMY, DEVELOPED OVER 248 CASES, CAN BE PERFORMED SAFELY. IT IS AN EASILY REPLICABLE TECHNIQUE. THIS PROCEDURE REDUCES THE MORBIDITY ASSOCIATED WITH ABDOMINAL RADICAL HYSTERECTOMY. ALL OF THE COMPLICATIONS CAN ALSO BE TACKLED LAPAROSCOPICALLY, WHICH DOES NOT FURTHER ADD TO THE MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284670 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention