BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7667454 · Received July 6, 2018

    Report

    Report Number
    2210968-2018-74145
    Event Type
    Injury
    Date Received
    July 6, 2018
    Report Date
    June 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. 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: SURGICAL INFECTIONS. 2014; 15. DOI: 10.1089/SUR.2013.143. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: FISTULA OUTPUT MICROORGANISM-SUSCEPTIBLE ANTIMICROBIAL PROPHYLAXIS IS ASSOCIATED WITH A LOWER RISK OF SURGICAL SITE INFECTION IN GASTROINTESTINAL FISTULA PATIENTS UNDERGOING ONE-STAGE DEFINITIVE SURGERY". AUTHOR: YUE-PING FAN, JIAN-AN REN, YUN-ZHAO ZHAO, GUO-SHENG GU, KUN ZHAO, AND JIE-SHOU LI. CITATION: SURGICAL INFECTIONS. 2014; 15. DOI: 10.1089/SUR.2013.143. EMPIRIC BROAD-SPECTRUM ANTIMICROBIAL PROPHYLAXIS (AMP) MAY NOT BE SUFFICIENT TO MINIMIZE THE RISK OF SURGICAL SITE INFECTIONS (SSIS) AFTER DEFINITIVE SURGICAL TREATMENT OF GASTROINTESTINAL (GI) FISTULA. THIS STUDY INVESTIGATES WHETHER AMP TARGETED TOWARD FISTULA MICROBIOLOGY IS ASSOCIATED WITH A LOWER RISK OF SSIS IN GI FISTULA PATIENTS UNDERGOING ONE-STAGE DEFINITIVE SURGERY. A TOTAL OF 191 PATIENTS (139 MALE AND 52 FEMALE PATIENTS; AGE 45.4 ± 14.2; BMI 19.6 ± 3.0) WERE EXAMINED AND INCLUDED IN THE STUDY ANALYSIS. DURING THE SURGICAL PROCEDURE, INTRAVENOUS INFUSION OF THE SELECTED AMP AGENT WAS STARTED 30¿60 MIN BEFORE MAKING THE FIRST SURGICAL INCISION. THE SELECTION OF THE GIVEN AMP AGENT FOR EACH PATIENT WAS AT THE DISCRETION OF THE ATTENDING SURGEON IN ACCORDANCE WITH THE INSTITUTIONAL GUIDELINES. THE PERITONEUM, LINEA ALBA, AND RECTUS SHEATH WERE CLOSED USING ABSORBABLE PDS-II SUTURES IN A CONTINUOUS MANNER. THE SUBCUTANEOUS TISSUE AND SKIN WERE CLOSED USING NON-ABSORBABLE MERSILK SUTURES IN AN INTERRUPTED MANNER. RELAXATION SUTURES WERE USED IN THE CASE OF HIGH INTRA-ABDOMINAL PRESSURE. REPORTED COMPLICATIONS INCLUDED SUPERFICIAL SSI (N-36) WHICH WAS RESOLVED BY MEDICAL TREATMENT, DEEP INCISIONAL SSI (N-8) WHICH WAS RESOLVED BY MEDICAL TREATMENT, ORGAN/SPACE SSI (N-7) WHICH REQUIRED SECONDARY SURGICAL TREATMENT (N-4), RECURRENT FISTULA (N-7) WHICH REQUIRED FURTHER SPECIFIC INTERVENTION DURING THE FOLLOW-UP PERIOD, AND BACTERIAL COLONIZATION (N-71; E. COLI, ENTEROCOCCUS SPP., K. PNEUMONIAE, S. AUREUS, PROTEUS SPP., P. AERUGINOSA, CITROBACTER SPP., D-GROUP STREPTOCOCCUS, MORGANELLA SPP., ENTEROBACTER SPP., AEROMONAS SPP.). IT WAS REPORTED THAT THE PRE-EXISTING MICROBIAL PATHOGENS AT THE SURGICAL SITE ARE BELIEVED TO BE THE PRIMARY CONTRIBUTING FACTOR OF SSI OCCURRENCE. THE GOAL OF USING AMP IS TO SUPPRESS, RATHER THAN ERADICATE, MICROBIAL GROWTH FOLLOWING SURGERY. THE OUTCOME HOWEVER, DEPENDS MAINLY ON THE SENSITIVENESS OF THE SPECIFIC COLONIZING PATHOGENS TO THE GIVEN AMP AGENT. IT WAS CONCLUDED THAT AMP TARGETED TOWARD FISTULA OUTPUT AMP MAY MINIMIZE THE OCCURRENCE OF SSIS AFTER ONE-STAGE DEFINITIVE SURGICAL TREATMENT OF GI FISTULA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510493 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention