BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 7727292 · Received July 27, 2018

    Report

    Report Number
    3005075853-2018-11606
    Event Type
    Injury
    Date Received
    July 27, 2018
    Report Date
    July 2, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036013003
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. 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 ARTICLE ENTITLED: DOES THE REMOVAL OF RETAINED STAPLES REALLY IMPROVE POSTOPERATIVE CHRONIC SEQUELAE AFTER TRANSANAL STAPLED OPERATIONS? AUTHOR : FRANCESCO SAVERIO MARI, M.D. ¿ GIUSEPPE NIGRI, M.D., F.R.C.S. TATIANA DI CESARE, M.D. ¿ MARCELLO GASPARRINI, M.D. ¿ BARBARA FLORA, M.D. CAROLA SEBASTIANI, M.D. ¿ ALESSANDRA PANCALDI, M.D. ¿ ANTONIO BRESCIA, M.D.. CITATION: DIS COLON RECTUM 2014; 57: 658¿662; DOI: 10.1097/DCR.0000000000000024. THIS RETROSPECTIVE STUDY AIMED TO ASSESS WHETHER THE REMOVAL OF THE RETAINED STAPLES IS A USEFUL APPROACH TO IMPROVE SOME OF THE MOST COMMON POSTOPERATIVE COMPLICATIONS OF THESE SURGICAL TECHNIQUE. FROM JAN2003 TO DEC2011, 566 PATIENTS (N=222 MALE AND N=344 FEMALE; MEAN AGE SD OF 53.0 ± 16.4 YEARS) WITH ANORECTAL DISEASE UNDERWENT TRANSANAL STAPLING PROCEDURES: STAPLED HEMORRHOIDOPEXY (SH) (N=308), STAPLED TRANSANAL RECTAL RESECTION (STARR) (N=78), AND TRANSTAR PROCEDURE (TP) (N=180). IN PATIENTS WHO UNDERWENT SH, PPH01 OR PPH03 STAPLER WERE USED. IN PATIENTS WHO UNDERWENT TP, TRANSTAR CCS-30 STAPLER WAS USED. POSTOPERATIVELY, THERE WERE PATIENTS WHO REPORTED PAIN AND BLEEDING. AT 3-MONTH FOLLOW-UP VISIT, 65 PATIENTS HAD CONTINUED TENESMUS, URGENCY, RECTAL HEAVINESS, OR MUCUS DISCHARGE WHICH WERE TREATED WITH STEROID LOCAL THERAPY. FOURTEEN PATIENTS HAD CHRONIC PAIN AND UNDERWENT STAPLE REMOVAL WHICH THE SYMPTOMATOLOGY SIGNIFICANTLY IMPROVED, WITH COMPLETE PAIN DISAPPEARING WITHIN 2 WEEKS. EIGHT PATIENTS HAD PERSISTENT MINOR RECTAL BLEEDING WHERE 1 OR MORE POLYPS WAS FOUND AT THE SITE OF THE RETAINED STAPLES; THESE PATIENTS UNDERWENT ENDOSCOPIC REMOVAL OF POLYPS AND RETAINED STAPLES AND THIS MANEUVER COMPLETELY STOPPED THE BLEEDING. AT 6-MONTH FOLLOW-UP, 51 PATIENTS HAD CONTINUED TENESMUS, URGENCY, RECTAL HEAVINESS, OR MUCUS DISCHARGE WHERE 44 OF THESE HAD 1 OR MORE STAPLES NOTED AND REMOVED. SYMPTOMS RESOLVED IN 28 PATIENTS AND IMPROVED IN 15; ONLY ONE CASE OF RETAINED STAPLE REMOVAL HAD PERSISTENT SYMPTOMS AT 12-MONTH VISIT. NONE OF THE 15 PATIENTS WITH IMPROVED SYMPTOMS AFTER RETAINED STAPLE REMOVAL SHOWED SYMPTOMS AT THE 12-MONTH FOLLOW-UP VISIT. POSTOPERATIVE PAIN IS ANOTHER SEVERE COMPLICATION AFTER TRANSANAL STAPLING PROCEDURES. THIS IS RELATED TO SEVERAL POSSIBLE CAUSES, INCLUDING PLACEMENT OF THE STAPLE LINE CLOSE TO THE DENTATE LINE, PLACEMENT OF HEMOSTATIC STITCHES. IF THE PAIN IS LOCALIZED TO A LIMITED REGION OF THE RECTUM, IT IS RELATED TO THE PRESENCE OF RETAINED STAPLES. AFTER TRANSANAL STAPLED PROCEDURES, THE PRESENCE OF RETAINED STAPLES SHOULD ALWAYS BE SUSPECTED IN THE CASE OF TENESMUS, URGENCY, PAIN, OR BLEEDING FOR >3 MONTHS AFTER SURGERY. A PRUDENT CONDUCT AND AN INTERVAL OF 3 TO 6 MONTHS BETWEEN THE INTERVENTION AND THE REMOVAL OF STAPLES SHOULD BE CONSIDERED TO AVOID UNNECESSARY INTERVENTIONS AND TO REDUCE THE RISK OF COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568951 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036013003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention