BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 9332194 · Received November 15, 2019

    Report

    Report Number
    1219930-2019-06397
    Event Type
    Injury
    Date Received
    November 15, 2019
    Report Date
    November 15, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: FEASIBILITY OF A NOVEL LAPAROSCOPIC TECHNIQUE WITH UNIDIRECTIONAL KNOTLESS BARED SUTURES FOR THE PRIMARY CLOSURE OF DUODENAL ULCER PERFORATION. SOURCE: SURGICAL ENDOSCOPY. 32 (3667-3674), 2018. DATE OF ONLINE PUBLICATION: 22 FEB 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, BETWEEN NOVEMBER 2009 AND OCTOBER 2015, THERE WERE 116 PATIENTS INCLUDED IN THE STUDY, 51 WERE IN GROUP "V" WHICH UTILIZED THE BARBED SUTURES AND PRESENTED THE FOLLOWING CASES; 1 FLUID COLLECTION AND 1 STRICTURE. THE NASOGASTRIC TUBE WAS MAINTAINED UNTIL THE SECOND DAY AFTER SURGERY AND THEN REMOVED AFTER CONFIRMING THAT NO GASTRIC RETENTION WAS PRESENT. ON THE THIRD OR FOURTH POSTOPERATIVE DAY, ACCORDING TO THE DEGREE OF PERITONEAL INFLAMMATION AND SEVERITY OF INFECTION, RADIOCONTRAST UPPER GASTROINTESTINAL FLUOROSCOPY WAS PERFORMED TO DETECT SUTURE SITE LEAKAGE OR STRICTURE. THE DIET WAS ADVANCED ONLY AFTER THIS CONFIRMATION WAS MADE, AND INTRAVENOUS ANTIBIOTICS WERE DISCONTINUED AFTER INFECTIOUS PERITONITIS OR ANY RELATED INFECTIONS HAD RESOLVED. THE CLOSED DRAIN WAS REMOVED AFTER BODY FLUID ANALYSIS FOR AMYLASE AND BILIRUBIN; THE PATIENT WAS DISCHARGED WHEN AN ADVANCED DIET WAS TOLERATED WITHOUT COMPLICATION. THE UREA BREATH TEST (UBT) WAS PERFORMED IN ALL PATIENTS WITH A SUSPICION OF PERFORATED PEPTIC ULCER (PPU) AT THE TIME OF DIAGNOSIS IN THE EMERGENCY CENTER. ALL PATIENTS WHO UNDERWENT SURGERY RECEIVED PPI M EDICATION FOR 2 MONTHS, AND WHEN PATIENTS WERE UBT POSITIVE, A 2-WEEK COURSE OF TRIPLE THERAPY (PPI + CLARITHROMYCIN/METRONIDAZOLE + AMOXICILLIN) FOR HELICOBACTER PYLORI (HP) ERADICATION WAS STARTED BEFORE DISCHARGE. FOLLOW-UP ENDOSCOPY WITH A CAMPYLOBACTER-LIKE ORGANISM (CLO) TEST WAS PERFORMED IN ALL PATIENTS 3 MONTHS AFTER SURGERY. A 2-WEEK COURSE OF TRIPLE THERAPY WAS STARTED IN THOSE WHO SHOWED A POSITIVE CLO TEST, AND QUADRUPLE THERAPY WAS STARTED IN PATIENTS WHO SHOWED PERSISTENT POSITIVE CLO RESULTS AFTER TRIPLE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122890 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN-VLOC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention