BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9344315 · Received November 19, 2019

    Report

    Report Number
    2210968-2019-90106
    Event Type
    Injury
    Date Received
    November 19, 2019
    Report Date
    October 31, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    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. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: LANGENBECKS ARCH SURG (2008) 393:627¿631, DOI 10.1007/S00423-008-0380-9. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE : THE USE OF ¿HARMONIC SCALPEL¿ VERSUS ¿KNOT TYING¿ FOR CONVENTIONAL ¿OPEN¿ THYROIDECTOMY: RESULTS OF A PROSPECTIVE RANDOMIZED STUDY" AUTHOR : CELESTINO PIO LOMBARDI & MARCO RAFFAELLI & AMERICO CICCHETTI & MARCO MARCHETTI & CARMELA DE CREA & ROSSELLA DI BIDINO & LUIGI ORAGANO & ROCCO BELLANTONE. CITATION: LANGENBECKS ARCH SURG (2008) 393:627¿631, DOI 10.1007/S00423-008-0380-9. THIS PROSPECTIVE RANDOMIZED STUDY AIMED TO EVALUATE THE EFFICIENCY, SAFETY, COST EFFECTIVENESS AND THE IMPACT ON THE SURGICAL OUTCOME OF THE UTILIZATION OF THE HARMONIC SCALPEL (HS) DURING CONVENTIONAL ¿OPEN¿ THYROIDECTOMY (CT). BETWEEN MARCH AND DECEMBER 2007, A TOTAL OF 200 PATIENTS SCHEDULED FOR CONVENTIONAL ¿OPEN¿ TOTAL THYROIDECTOMY (TT) WERE RANDOMLY ASSIGNED TO TT WITH THE USE OF HS (HS GROUP) (N=100 [N=25 MALE N=75 FEMALE, MEAN AGE OF 49.5 YEARS, RANGE 20-72]) OR WITH THE KNOT TYING TECHNIQUE (KT GROUP) (N=100[N=22 MALE N=78 FEMALE, MEAN AGE OF 52.5, RANGE 25-74]). IN PATIENTS OF THE KT GROUP, THE UPPER, MIDDLE AND INFERIOR VESSELS WERE DIVIDED AFTER BEING TIED WITH CONVENTIONAL LIGATURES (POLYGLACTIN 910, 2/0 AND 3/0 AS REQUIRED; VICRYL, ETHICON ENDO-SURGERY). IN PATIENTS OF THE HS GROUP, DIVISION OF THE UPPER, MIDDLE AND INFERIOR VESSELS WAS OBTAINED WITH THE OPEN SHEAR SCISSOR GRIP CS-14C (HARMONIC, ETHICON ENDO-SURGERY), WHERE ACTIVE SHEAR IS UP AND THE INACTIVE SHEAR NEAR THE TISSUE TO INSURE MINIMAL THERMAL INJURY. COMPLAINT INCLUDED BLEEDING (N=1 HS GROUP, N=1 KT GROUP) AND TRANSIENT RECURRENT NERVE PALSY (N=2 HS GROUP, N=1 KT GROUP). PATIENTS WHO HAD BLEEDING COMPLICATIONS REQUIRED RE-OPERATION. HS IS A SAFE, EFFICACIOUS AND COST-EFFECTIVE ALTERNATIVE TO KNOT TYING TECHNIQUE FOR CT, ALLOWING FOR A SIGNIFICANT REDUCTION OF OPERATIVE TIME (ABOUT 30%) WITHOUT INCREASING COMPLICATIONS RATE AND OVERALL COSTS OF THE PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136159 POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention