BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12686780 · Received October 24, 2021

    Report

    Report Number
    2210968-2021-10225
    Event Type
    Injury
    Date Received
    October 24, 2021
    Date of Event
    March 9, 2020
    Report Date
    October 24, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (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 OBSTETRICS AND GYNAECOLOGY 2021, VOL. 41, NO. 1, 106¿111:HTTPS://DOI.ORG/10.1080/01443615.2020.1718626. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT THE ETHICON PRODUCTS (STRATAFIX SUTURE AND 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 PRODUCTS INVOLVED? PATIENT DEMOGRAPHICS? EVENTS RELATED TO STRATAFIX SUTURE DEVICE REPORTED VIA MW #2210968-2021-10224. EVENTS RELATED TO VICRYL SUTURE DEVICE REPORTED VIA THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: LEAK-PROOF TECHNIQUE IN LAPAROSCOPIC SURGERY FOR LARGE OVARIAN CYSTS. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF THE LEAK-PROOF EXTRACORPOREAL ASPIRATION TECHNIQUE IN LAPAROSCOPY FOR EXTREMELY LARGE OVARIAN CYSTS AND COMPARE OPERATIVE OUTCOMES, COMPLICATIONS, AND CYST SPILLAGE RATES WITH THE CONVENTIONAL LAPAROSCOPIC TECHNIQUE. BETWEEN FEBRUARY 2017 AND JUNE 2019, 35 CONSECUTIVE PATIENTS UNDERWENT LAPAROSCOPIC OVARIAN SURGERY WITH THE LEAK-PROOF TECHNIQUE (THE PRACTICE CHANGE COHORT) AND CYST CONTENTS SPILLAGE RATES WERE RETROSPECTIVELY COMPARED WITH 35 CASE-MATCHED CONSECUTIVE PATIENTS WHO UNDERWENT CONVENTIONAL LAPAROSCOPY WITHOUT THE LEAK-PROOF TECHNIQUE (THE HISTORICAL COHORT) BETWEEN JULY 2014 AND OCTOBER 2016. THE MEAN AGE AND BODY MASS INDEX OF THE STUDY PATIENTS WERE 44.7 ± 5.8 YEARS AND 25.0 ± 4.4 KG/M2, RESPECTIVELY; NO STATISTICAL SIGNIFICANCE WAS SEEN BETWEEN THE TWO COHORTS. THE MEAN CYST SIZE AND PREOPERATIVE CA125 LEVELS WERE 20.7 ± 4.8 CM AND 26.1 ± 16.9 IU/ ML, RESPECTIVELY; NO STATISTICAL SIGNIFICANCE WAS SEEN BETWEEN THE COHORTS. IN PATIENTS OF THE PRACTICE CHANGE COHORT USING AN OPEN HASSON TECHNIQUE WITHIN THE UMBILICUS. AFTER IDENTIFYING THE OVARIAN SURFACE THROUGH THE UMBILICAL OPENING UNDER DIRECT VISION, THE TOPICAL SKIN ADHESIVE (DERMABOND; ETHICON, SOMERVILLE, NJ, USA) WAS APPLIED TO THE SURFACE AREA OF THE OVARIAN CYST. A TRANSPARENT VINYL MEMBRANE MADE FROM A STERILE DISPOSABLE VINYL GLOVE (POLYGLOVE, KOREA YANG HAENG, SEOUL, KOREA) WAS ATTACHED TO THE OVARIAN SURFACE WHICH APPLIED TO THE SKIN ADHESIVE, AND BRIEF PRESSURE WITH DRY GAUZE WAS USED TO PUSH THE VINYL MEMBRANE TOWARDS THE CYST WALL UNTIL THE SKIN ADHESIVE WAS SET. AFTER CONFIRMING THE COMPLETE ADHERENCE OF VINYL MEMBRANE TO THE OVARIAN SURFACE, AN INCISION OF ABOUT 0.3 CM WAS MADE OVER THE AREA WHERE THE VINYL MEMBRANE FIRMLY ADHERED TO THE OVARIAN SURFACE, AND A SUCTION TUBE WAS QUICKLY INSERTED INTO THE CYST THROUGH THIS INCISION. AN ADDITIONAL SUCTION TUBE WAS PLACED ON TO A VINYL MEMBRANE TO ASPIRATE THE CYST FLUID OVERFLOWED OUTSIDE OF THE INCISION SITE. THE CYST FLUID WAS ASPIRATED THROUGH A SUCTION TUBE AND THE COLLAPSED OVARY EXTRACTED OUTSIDE THE ABDOMINAL CAVITY. THEN, THE CYST SURFACE ATTACHING A VINYL MEMBRANE USING THE TOPICAL ADHESIVE WAS EXTRACORPOREALLY EXCISED TO AVOID INTRAPERITONEAL EXPOSURE OF THE SKIN ADHESIVE AND RESULTANT COMPLICATION. IF PATIENTS WERE INDICATED FOR OVARIAN CYSTECTOMY DURING PREOPERATIVE COUNSELLING, CYSTECTOMY WAS EXTRACORPOREALLY PERFORMED, SIMILARLY TO LAPAROTOMY, AS WE PREVIOUSLY REPORTED (SONG ET AL. 2014). BECAUSE THE SALPINX, INFUNDIBULOPELVIC LIGAMENT, AND UTERO-OVARIAN LIGAMENT WERE ELONGATED ALONG THE DIRECTION OF UPPER ABDOMINAL CAVITY, ADNEXAL STRUCTURES WAS SEEN JUST BELOW THE WOUND RETRACTOR PLACED IN UMBILICAL OPENING. AFTER COMPLETION OF THE OVARIAN CYSTECTOMY, THE OVARY WAS RECONSTITUTED WITH 2-0 VICRYL SUTURES (ETHICON). ONCE THE EXTRACORPOREAL PROCESS WAS COMPLETED, THE OVARY WAS RETURNED TO THE ABDOMINAL CAVITY THROUGH THE UMBILICAL PORT. IN PATIENTS WHO WERE INDICATED ADNEXECTOMY, LAPAROSCOPIC ADNEXECTOMY WAS THEN PERFORMED SIMILARLY TO CONVENTIONAL LAPAROSCOPY, AS WE PREVIOUSLY REPORTED (SONG ET AL. 2012). AFTER THE ABDOMINAL CAVITY WAS CAREFULLY INSPECTED TO IDENTIFY ANY BLEEDING FOCI AND WAS IRRIGATED WITH NORMAL SALINE. THE TRANSUMBILICAL FASCIA WAS APPROXIMATED USING A 1-0 VICRYL RUNNING SUTURE (ETHICON), AND THE SKIN WAS CLOSED SUBCUTICULARLY USING A 4-0 STRATAFIX SUTURE (ETHICON). IN PATIENTS OF THE HISTORICAL COHORT, LAPAROENDOSCOPIC SINGLE- SITE SURGERY USING THE GLOVEPORT WAS ALSO PERFORMED SIMILARLY TO THAT IN PATIENTS OF THE PRACTICE CHANGE COHORT. AS WE PREVIOUSLY REPORTED (SONG ET AL. 2014), THE SURFACE OF A HUGE OVARIAN CYST WAS EXPOSED THROUGH THE UMBILICAL OPENING UNDER DIRECT VISION, AND THE INTERNAL MARGIN OF THE WOUND RETRACTOR WAS FENCED WITH A PIECE OF SURGICAL GAUZE TO MINIMISE LEAKAGE OF CYST CONTENT DURING THE ASPIRATION OF THE OVARIAN CYST. A PURSE-STRING SUTURE USING 3-0 VICRYL (ETHICON) WAS THEN APPLIED TO THE OVARIAN CYST UNDER DIRECT VISION. WHILE PULLING A PURSE-STRING SUTURE OUT OF THE UMBILICAL OPENING, THE CYST CONTENT WAS RAPIDLY ASPIRATED WITH A SUCTION TUBE AFTER PUNCTURING THE OVARIAN CYST. THE SUBSEQUENT PROCEDURE WAS IDENTICAL TO THE PRACTICE CHANGE COHORT. DURING THE 1-MONTH PERIOD AFTER SURGERY, THERE WERE 2 POSTOPERATIVE COMPLICATIONS: ONE CASE OF ILEUS REQUIRING PROLONGED HOSPITAL STAY UNTIL THE FOURTH POSTOPERATIVE DAY AND ONE CASE OF WOUND INFECTION THAT TREATED WITH ORAL ANTIBIOTICS WITHOUT SURGICAL INTERVENTION. DERMABONDTM (A 2-OCTYLCYANOACRYLATE TISSUE ADHESIVE) AND A VINYL MEMBRANE (MADE FROM A TRANSPARENT STERILE VINYL GLOVE) AS THE MEDICAL DEVICES FOR THE LEAKPROOF TECHNIQUE SUITABLE IN THE LAPAROSCOPIC SETTING. NO SPILLAGE OF CYST CONTENT OCCURRED DESPITE A SMALL SKIN INCISION OF 2 CM IN AN OBESE PATIENT. REPORTED POSTOPERATIVE COMPLICATIONS INCLUDED N=1 WOUND INFECTION. IN CONCLUSION, LAPAROSCOPY WITH THE LEAK-PROOF TECHNIQUE IS RELIABLE, SAFE, AND EASILY IMPLEMENTED IN THE MANAGEMENT OF SELECTED PATIENTS WITH LARGE OVARIAN TUMOURS AND LOW PROBABILITY OF MALIGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584832 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention