BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8837677 · Received July 29, 2019

    Report

    Report Number
    2210968-2019-84807
    Event Type
    Injury
    Date Received
    July 29, 2019
    Report Date
    July 2, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: J GASTROINTEST SURG (2010); 14:739¿742. DOI: 10.1007/S11605-009-1114-1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE TITLE: MODIFIED STAPLED TRANSANAL RECTAL RESECTION (STARR) FOR FULL THICKNESS EXCISION OF RECTAL TUMOUR. TRADITIONALLY, ADENOMATOUS RECTAL LESIONS AND UNEXPECTED MALIGNANT POLYPS THAT COULD NOT BE REMOVED ENDOSCOPICALLY ARE REFERRED TO SURGERY. LOCAL EXCISION IS THE TREATMENT OF CHOICE, AND SEVERAL TECHNIQUES HAVE BEEN PROPOSED. THE AUTHORS DESCRIBE A MODIFIED STAPLED TRANSANAL RECTAL RESECTION FOR THE EXCISION OF FLAT LESIONS WITH A DIAMETER UP TO 2 CM AND LOCATED BETWEEN 5 AND 12 CM FROM THE ANAL VERGE. FIVE PATIENTS (4 MALE AND 1 FEMALE) UNDERWENT THIS MODIFIED STAPLED TRANSANAL RECTAL RESECTION (STARR). A CIRCULAR STAPLER DEVICE IS USED. A DISPOSABLE CIRCULAR ANAL DILATOR AND A PURSE-STRING SUTURE ANOSCOPE ARE USED AS FOR A PPH PROCEDURE (PPH01; ETHICON). USING A 2-0 PROLENE (ETHICON), A 180 DEGREE PURSE-STRING SUTURE IS PERFORMED AT LEAST 1 CM ABOVE THE RECTAL TUMOUR. REPORTED COMPLICATIONS INCLUDED BLEEDING (N-2) IN WHICH ADDITIONAL HEMOSTATIC SUTURES WERE NEEDED, AND TENESMUS THAT LASTED UP TO 5 MONTHS AFTER SURGERY (N-1).IN CONCLUSION, THE TECHNIQUE OVERCOMES SOME OF THE LIMITS OF THE INCOMPLETE SURGICAL FIELD EXPOSURE AND DIFFICULT MANIPULATION, SINCE AFTER THE PLACEMENT OF THE PURSE-STRING SUTURES, THE RESECTION IS PERFORMED BY THE STAPLER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629394 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention