BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE BLU 75CM 2-0 ST-70(2)

    MDR report key: 7616553 · Received June 19, 2018

    Report

    Report Number
    2210968-2018-73568
    Event Type
    Injury
    Date Received
    June 19, 2018
    Report Date
    May 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 2015; 22 (5). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: OVARIAN SUSPENSION WITH ADJUSTABLE SUTURES: AN EASY AND HELPFUL TECHNIQUE FOR FACILITATING LAPAROENDOSCOPIC SINGLE-SITE GYNECOLOGIC SURGERY AUTHORS: KUO-HU CHEN, MD, PHD; LI-RU CHEN, MD, MSC; KOK-MIN SEOW, MD, PHD CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 2015; 22 (5) DOI: HTTP://DX.DOI.ORG/10.1016/J.JMIG.2015.02.018. THE OBJECTIVES OF THIS PROSPECTIVE COHORT STUDY WAS TO DESCRIBE A METHOD OF OVARIAN SUSPENSION WITH ADJUSTABLE SUTURES (OSAS) FOR FACILITATING LAPAROENDOSCOPIC SINGLE-SITE GYNECOLOGIC SURGERY (LESS) AND TO INVESTIGATE THE EFFECT OF OSAS ON LESS. A TOTAL OF 178 PATIENTS WITH BENIGN 5- TO 15-CM CYSTIC OVARIAN TUMORS UNDERWENT LESS WITH OSAS (SUSPENSION GROUP; N-90) AND WITHOUT OSAS (CONTROL GROUP; N-88) AND WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE IN THE SUSPENSION GROUP, THE SURGEON PALPATED THE ABDOMINAL SKIN OVERLYING THE TUMOR TO DETERMINE THE APPROPRIATE SITE FOR NEEDLE INSERTION AND OVARIAN SUSPENSION. ONE END OF DOUBLE-HEAD STRAIGHT NEEDLES WITH PROLENE 2-0 SUTURE WAS INSERTED INTO THE PELVIC CAVITY THROUGH THE ABDOMINAL SKIN TO LIFT, STABILIZE, OR RETRACT THE TUMOR OR OVARY BY PENETRATING THE CYST OR OVARIAN PARENCHYMA, AND PUNCTURING OUTSIDE THE ABDOMINAL SKIN. AFTER CUTTING OFF THE DOUBLE-HEAD NEEDLES, THE DOUBLE SIDES OF THE REMAINING SUTURE WERE HELD TOGETHER BY A CLAMP WITHOUT KNOTTING THE STITCHES SO THAT THE SURGEON OR ASSISTANT COULD LIFT, LOOSEN, OR FIX THE STITCHES TO ADJUST THE TENSION OF THE SUSPENSION ON DEMAND TO PERFORM A LAPAROENDOSCOPIC SINGLE-SITE OOPHORO-CYSTECTOMY. IN THE SUSPENSION GROUP, REPORTED COMPLICATION INCLUDED SUBCUTANEOUS HEMATOMA (N-1) WHICH RESOLVED SPONTANEOUSLY. ADDITIONAL COMPLICATIONS INCLUDE FEVER, WOUND INFECTION, ILEUS, AND GI OR GU TRACT INJURY REPORTED IN TABLE 2. IT WAS CONCLUDED THAT OSAS IS AN EASY, SAFE, AND FEASIBLE METHOD, WHICH WAS CONFIRMED TO REDUCE THE BLOOD LOSS, OPERATIVE TIME, AND INCIDENCE OF CONVERTING TO STANDARD NON¿SINGLE-SITE LAPAROSCOPY AND LAPAROTOMY WITHOUT INCREASING THE RISK OF COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458028 PROLENE BLU 75CM 2-0 ST-70(2) SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention