BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABS 2-0 GR 18 GS-21

    MDR report key: 5256939 · Received December 1, 2015

    Report

    Report Number
    1219930-2015-01039
    Event Type
    Injury
    Date Received
    December 1, 2015
    Report Date
    November 16, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAM
    PMA / PMN Number
    K111442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE AUTHOR, TATSUO NAKAGAWA: ONE CASE IN THE ARTICLE DEVELOPED ANASTOMOTIC STENOSIS AFTER SURGERY. HE WAS A (B)(6) YEAR-OLD MALE PERSON, 160CM TALL AND (B)(6) IN WEIGHT. HIS INITIAL IS (B)(6). THE ANASTOMOTIC STENOSIS WAS MOST PROBABLY DUE TO POSTOPERATIVE PNEUMONIA AND I BELIEVE THERE IS NO CAUSAL RELATIONSHIP BETWEEN PNEUMONIA AND V-LOC SUTURE BECAUSE THE PATIENT HAD A SEVERE COPD AND A DIFFICULTY OF SPITTING OUT AFTER SURGERY. THE LOT NUMBER OF THE DEVICE WAS NOT RECORDED.

    Additional Manufacturer Narrative · 1

    (B)(4). NAKAGAWA, TATSUO, CHIBA, NAOHISA, UEDA, YUICHIRO, SAITO, MASAO, SAKAGUCHI, YASUTO, + ISHIKAWA, SHINYA. (2015). CLINICAL EXPERIENCE OF SLEEVE LOBECTOMY WITH BRONCHOPLASTY USING A CONTINUOUS ABSORBABLE BARBED SUTURE. GEN THORAC CARDIOVASC SURG, VOLUME 63, PP. 640-643. DOI 10.1007/S11748-014-0517-4.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A CLINICAL STUDY WAS PERFORMED ON TWO PATIENTS AT (B)(6). THE REPORTER EXPERIENCED TWO CASES OF RIGHT SLEEVE UPPER LOBECTOMY INCLUDING ONE CASE OF COMPLETELY THORACOSCOPIC SURGERY AND TWO CASES OF UPPER-MIDDLE LOBECTOMY TO DATE USING CONTINUOUS SUTURING WITH THE V-LOCTM 180. THERE WERE NO SURGICAL PROBLEMS WITH THE BRONCHIAL ANASTOMOSIS SUCH AS CUTTING OR LOOSENING OF THE SUTURE, AND A LEAK TEST AFTER ANASTOMOSIS WAS NEGATIVE IN ALL CASES. ONE PATIENT DEVELOPED PNEUMONIA, WHICH WAS SUCCESSFULLY TREATED WITH ANTIBIOTIC THERAPY. BRONCHIAL STENOSIS IN THE ANASTOMOTIC AREA WAS FOUND IN THE SAME PATIENT 4 MONTHS POSTOPERATIVELY ON FOLLOW-UP FIBEROPTIC BRONCHOSCOPY, WHICH DID NOT REQUIRE TREATMENT. NAKAGAWA, TATSUO, CHIBA, NAOHISA, UEDA, YUICHIRO, SAITO, MASAO, SAKAGUCHI, YASUTO, + ISHIKAWA, SHINYA. (2015). CLINICAL EXPERIENCE OF SLEEVE LOBECTOMY WITH BRONCHOPLASTY USING A CONTINUOUS ABSORBABLE BARBED SUTURE. GEN THORAC CARDIOVASC SURG, VOLUME 63, PP. 640-643. DOI 10.1007/S11748-014-0517-4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788600 ABS 2-0 GR 18 GS-21 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN, FORMERLY US SURGICAL A DIVISON VLOC 180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention