BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*75MM LINEAR CUTTER

    MDR report key: 7743269 · Received August 2, 2018

    Report

    Report Number
    3005075853-2018-11814
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    July 9, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036013218
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: ONLY PUBLICATION YEAR (2013) IS KNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: MIDTERM RESULTS AFTER PERINEAL STAPLED PROLAPSE RESECTION FOR EXTERNAL RECTAL PROLAPSE AUTHOR: DIANA SEHMER, MD; LUKAS MARTI, MD; KATJA WOLFF, MD; FRANC H. HETZER, MD CITATION: DIS COLON RECTUM 2013; 56: 91¿96, DOI: 10.1097/DCR.0B013E31826CBBEA. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO REPORT THE MIDTERM RECURRENCE RATES AFTER PERINEAL STAPLED PROLAPSE RESECTION (PSP). SECONDARY AIMS WERE TO REPORT THE MIDTERM FUNCTIONAL RESULTS AND PATIENT SATISFACTION AFTER PSP. BETWEEN THE PERIODS OF NOVEMBER 2007 TO OCTOBER 2011, A TOTAL OF 56 PATIENTS (2 MEN, 3.6%) WITH EXTERNAL RECTAL PROLAPSE WERE TREATED BY THE USE OF THE PSP PROCEDURE. NOTABLY, 32 PATIENTS THAT WERE PART OF THE 2010 STUDY WERE ALSO INCLUDED IN THIS ANALYSIS. DURING THE PROCEDURES, THE PROLAPSE WAS CUT OPEN AT THE 3 O¿CLOCK POSITION WITH THE USE OF A HORIZONTAL STAPLER SUCH AS THE PROXIMATE 75-MM LINEAR CUTTER STAPLER (GIA STAPLER; TLC75; ETHICON ENDO-SURGERY, CINCINNATI, OH). AFTER OPENING THE PROLAPSE, AN ORIENTATION SUTURE WAS PLACED AT THE END OF THE STAPLE LINE. THE CONTOUR STAPLER (STR5G; ETHICON ENDO-SURGERY, CINCINNATI, OH) WAS INSERTED INTO THE PROLAPSE, AND THE PROLAPSE WAS RESECTED COUNTER CLOCKWISE IN SEVERAL STEPS. ONE PATIENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS DEVELOPED PERITONITIS 2 DAYS AFTER PSP BECAUSE OF A SMALL ANASTOMOSIS LEAKAGE AND WAS TREATED FOR 14 DAYS WITH ANTIBIOTICS (COMPLICATION GRADE II, NEEDING MEDICATION). TWO PATIENTS REQUIRED REINTERVENTION AFTER PSP AS A RESULT OF POSTOPERATIVE HEMORRHAGE (COMPLICATION GRADE IIIB, REQUIRING SURGICAL INTERVENTION UNDER GENERAL ANESTHESIA). THE BLEEDING WAS LOCALIZED AT THE STAPLE LINE AND WAS STOPPED BY TRANSANAL OVERSEWING. TWO PATIENTS HAD URINARY RETENTION: ONE RECOVERED SPONTANEOUSLY (COMPLICATION GRADE I), AND ONE NEEDED A SUPRAPUBIC CYSTOSTOMY FOR ABOUT 16 DAYS (COMPLICATION GRADE IIIA). IN CONCLUSION, PERINEAL STAPLED PROLAPSE RESECTION IS A GOOD ALTERNATIVE TO OTHER PERIANAL TECHNIQUES. IT IS A QUICK AND RELIABLE PROCEDURE THAT IS SUITABLE FOR PATIENTS OF ADVANCED AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587066 PROXIMATE*75MM LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036013218

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention