BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7670710 · Received July 9, 2018

    Report

    Report Number
    2210968-2018-74187
    Event Type
    Injury
    Date Received
    July 9, 2018
    Report Date
    June 14, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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: WORLD JOURNAL OF SURGICAL ONCOLOGY (2018) 16:74; DOI: HTTPS://DOI.ORG/10.1186/S12957-018-1374-X (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE : ROBOTIC SLEEVE RESECTION FOR PULMONARY DISEASE AUTHOR : CHENGQIANG LI, BIN ZHOU, YU HAN, RUNSEN JIN, JIE XIANG AND HECHENG LI CITATION: WORLD JOURNAL OF SURGICAL ONCOLOGY (2018) 16:74; DOI: HTTPS://DOI.ORG/10.1186/S12957-018-1374-X THIS STUDY AIMED TO REPORT SUCCESSFUL IMPLEMENTATION OF A COMPLETELY PORTAL ROBOTIC SLEEVE RESECTION WITH OR WITHOUT PULMONARY RESECTION USING A MODIFIED SUTURE MODE. FROM MAY2015 TO SEP2017, 339 PATIENTS UNDERWENT CURATIVE ROBOTIC PULMONARY SURGERY WHERE 3 PATIENTS (ALL MALE) UNDERWENT SLEEVE RESECTION. IN ROBOTIC SLEEVE RESECTION, A DOUBLE-ARMED 3-0 PROLENE SUTURE WAS USED TO PERFORMED END-TO-END BRONCHIAL ANASTOMOSIS USING A SIMPLE RUNNING SUTURE COMBINED WITH TWO INTERRUPTED SUTURES OF THE MEMBRANOUS AND CARTILAGINOUS JUNCTION PARTS. THE SIDE OF THE UPPER SEGMENT OF THE TRACHEA WAS NARROWED TO BETTER MATCH THE CALIBRE OF THE DISTAL SEGMENTAL BRONCHUS WITH 5-0 PROLENE. NARROW THE RIM OF LEFT UPPER LOBE BRONCHUS TO BETTER MATCH THE CALIBRE OF THE DISTAL SEGMENT BRONCHUS WITH A 5-0 PROLENE. END-TO-SIDE BRONCHIAL ANASTOMOSIS WAS PERFORMED BY A 5-0 PDS II CONTINUOUS RUNNING SUTURE. POSTOPERATIVELY, A (B)(6) MALE PATIENT WHO HAD LEFT LINGULAR SEGMENT RESECTION DEVELOPED SHORT-TERM ATELECTASIS WHICH WAS TREATED WITH BRONCHOSCOPE SPUTUM SUCTION AND ANTIBIOTIC TREATMENT AND ACHIEVED FULL RE-EXPANSION OF THE LINGULAR SEGMENT DURING FOLLOW-UP. THIS STUDY SUGGESTED THAT ROBOTIC SLEEVE RESECTION FOR PULMONARY DISEASE WITH OR WITHOUT PULMONARY RESECTION MAY BE SAFE AND EFFECTIVE. THE ANASTOMOSIS TIME CAN BE SHORTENED WITH MORE ROBOTIC SURGERY EXPERIENCES AND THE MODIFIED SUTURE MODE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513561 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention