BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7446985 · Received April 20, 2018

    Report

    Report Number
    2210968-2018-72205
    Event Type
    Injury
    Date Received
    April 20, 2018
    Report Date
    March 26, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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. CITATION: ASIAN CARDIOVASCULAR & THORACIC ANNALS. 2014; 22(3): 309 314. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿STAPLERS VERSUS HAND-SEWING FOR PULMONARY LOBECTOMY: RANDOMIZED CONTROLLED TRIAL¿ AUTHORS: APICHAT TANTRAWORASIN, SOMCHAREAN SEATEANG, NUTCHANART BUNCHUNGMONGKOL CITATION: ASIAN CARDIOVASCULAR & THORACIC ANNALS. 2014; 22(3): 309 314. DOI: 10.1177/0218492313491754 THE OBJECTIVES OF THIS NON-BLINDED RANDOMIZED CONTROLLED TRIAL WAS TO INVESTIGATE THE ADVANTAGE OF USING A STAPLER IN TERMS OF POST-OPERATIVE AIR LEAK AND COST COMPARED TO HAND-SEWN TECHNIQUES. A TOTAL OF 53 PATIENTS UNDERWENT AN ELECTIVE LOBECTOMY AND WERE RANDOMIZED TO UNDERGO A HAND-SEWN TECHNIQUE (CONTROL GROUP; 27 PATIENTS) OR STAPLER CLOSURE (STUDY GROUP; 26 PATIENTS). DURING THE SURGICAL PROCEDURE, THE CONTROL GROUP RECEIVED SUTURING WITH POLYDIOXANONE 4-0 SUTURE AND THE STUDY GROUP WERE TREATED WITH AN AUTOMATIC STAPLING DEVICE, A 60-MM LINEAR CUTTER STAPLER FOR PARENCHYMAL LUNG DIVISION. IN THE CONTROL GROUP, REPORTED COMPLICATIONS INCLUDED POST-OPERATIVE AIR LEAK (N-8), IN WHICH 2 PATIENTS UNDERWENT SECONDARY THORACOTOMY. IT WAS REPORTED THAT PATIENTS IN THE STUDY GROUP HAD A SIGNIFICANTLY LOWER RISK OF POST-OPERATIVE AIR LEAK COMPARED TO THE CONTROL GROUP. TWO POSSIBLE REASONS ARE THAT THE HOLES CREATED BY THE SUTURE NEEDLES AT THE CUT EDGE OF THE LOBE MAY INVITE AIR LEAKAGE IN THE HAND-SEWN SUTURE CLOSURE TECHNIQUE, AND THE TECHNIQUE OF HAND-SEWN CLOSURE OF LUNG PARENCHYMA DEPENDS ON THE EXPERIENCE OF EACH SURGEON. IT WAS CONCLUDED THAT STAPLER CLOSURE REDUCES POST-OPERATIVE AIR LEAKS AND THE DURATION OF AIR LEAKS THAN THE HAND-SEWN CLOSURE TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289385 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention