BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*75MM LINEAR CUTTER

    MDR report key: 8655425 · Received May 30, 2019

    Report

    Report Number
    3005075853-2019-19400
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    January 1, 2018
    Report Date
    May 10, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013211
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). DATE OF EVENT: ONLY PUBLICATION YEAR (2018) IS KNOWN. BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS THROUGH A JOURNAL ARTICLE. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED AND IT IS UNKNOWN IF THE EVENTS HAVE BEEN PREVIOUSLY REPORTED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (LINEAR STAPLER TLC75) 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 (LINEAR STAPLER TLC75) USED IN THIS PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: PERINEAL STAPLED RECTAL PROLAPSE RESECTION IN ELDERLY PATIENTS: LONG-TERM FOLLOW-UP. AUTHOR: EDWARD RAM, M.D. AVIAD HOFFMAN, M.D. YURI GOLDES, M.D. DANNY ROSIN, M.D. NIR HORESH, M.D. MORDECHAI GUTMAN, M.D. YAIR EDDEN, M.D. CITATION: DISEASES OF THE COLON & RECTUM (2018); 61: 1316¿1319. DOI: 10.1097/DCR.0000000000001215. THE AIM OF THIS STUDY WAS TO ASSESS THE LONG-TERM RESULTS OF PERINEAL STAPLED PROLAPSE RESECTION (PSPR), FOCUSING ON MORBIDITY, RECURRENCE RATE, AND FUNCTIONAL OUTCOME. BETWEEN JANUARY 2010 TO JUNE 2013, 30 PATIENTS (2 MALE AND 28 FEMALE; AGE RANGE: 67-96 YEARS) WITH FULL-THICKNESS RECTAL PROLAPSE AND DAILY FECAL INCONTINENCE (FI) THAT WERE NOT SUITABLE FOR ABDOMINAL OR EXTENDED SURGERY THAT UNDERWENT PERINEAL STAPLED RECTAL RESECTION WERE INCLUDED IN THIS STUDY. THE OPERATION COMMENCES WITH RECTAL PROLAPSE EXTRACTION FOLLOWED BY LATERAL DIVISION OF THE PROLAPSE AT THE 3 O¿CLOCK POSITION BY USING A LINEAR STAPLER TLC75 (ETHICON) SO THAT THE STAPLER LINE ENDS 2 CM ABOVE THE DENTATE LINE. CONTOUR TRANSTAR STAPLER (ETHICON) IS INSERTED INTO THE PROLAPSED RECTUM AND TURNED IN A COUNTERCLOCKWISE FASHION OVER THE PROLAPSE EXTENT. THE STAPLE LINE WAS THEN OVERSEWN WITH A RUNNING VICRYL 2/0 SUTURE (ETHICON) TO ENSURE THE INTEGRITY OF THE STAPLE LINE AND IMPROVED HEMOSTASIS. REPORTED COMPLICATIONS INCLUDED RECURRENT RECTAL PROLAPSE (N-6) IN WHICH 4 PATIENTS UNDERWENT ALTEMEIER PROCEDURE AND 2 PATIENTS HAD A REDO-PSPR PROCEDURE, AND POSTOPERATIVE FECAL INCONTINENCE (N-30) IN CONCLUSION, FRAIL PATIENTS THAT CAN ONLY ENDURE A SHORT PROCEDURE UNDER REGIONAL ANESTHESIA SHOULD BE CONSIDERED FOR PSPR. THE LACK OF MORTALITY AND MORBIDITY, SPECIFICALLY IN THIS POPULATION, COMBINED WITH THE LOW SUSTAINING LONG-TERM RECURRENCE RATES, MAKE THIS SURGICAL ALTERNATIVE A CONSIDERABLE ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447058 PROXIMATE*75MM LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013211

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention