BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8731473 · Received June 25, 2019

    Report

    Report Number
    3005075853-2019-20042
    Event Type
    Injury
    Date Received
    June 25, 2019
    Date of Event
    January 1, 2008
    Report Date
    May 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012993
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2008. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: STAPLED TRANSANAL RECTAL RESECTION FOR OUTLET OBSTRUCTION SYNDROME: RESULTS AND FOLLOW-UP. AUTHOR(S): MARCO FRASCIO, CESARE STABILINI, BARBARA RICCI, PAOLO MARINO, ROSARIO FORNARO, LUIGI DE SALVO, FRANCESCA MANDOLFINO, FABRIZIO LAZZARA, EZIO GIANETTA. CITATION: WORLD J SURG (2008) 32:1110¿1115; DOI 10.1007/S00268-008-9540-X. THIS PROSPECTIVE STUDY WAS DESIGNED TO ASSESS SAFETY AND EFFECTIVENESS OF STAPLED TRANSANAL RECTAL RESECTION (STARR) IN A CAREFULLY SELECTED SERIES OF PATIENTS AFFECTED BY OUTLET OBSTRUCTION SYNDROME (OOS) RESULTING FROM A COMBINATION OF INTUSSUSCEPTION AND RECTOCELE. FROM JUL2000 TO MAR2007, 25 PATIENTS (N=19 FEMALE AND N=6 MALE; MEAN AGE AT SURGERY 55 ± 16.1 YEARS) WITH OOS IN WHOM A COMBINATION OF INTUSSUSCEPTION AND RECTOCELE WERE INCLUDED IN THE STUDY. IN THE PROCEDURE, TWO OR THREE SEPARATE ONE-HALF PURSE-STRING SUTURES (PROLENE 2-0) WERE INSERTED ABOVE THE HEMORRHOIDAL APEX TO INCLUDE THE TOP OF RECTOCELE AND INTERNAL RECTAL PROLAPSE. THE 33-MM CIRCULAR STAPLER SPECIFICALLY DESIGNED FOR THIS PROCEDURE (PPH-01, ETHICON ENDO-SURGERY, INC., POMEZIA, ITALY) WAS OPENED, AND THE ANVIL PLACED ABOVE THE ANTERIOR ONE-HALF PURSE STRINGS. THE PROCEDURE WAS THEN REPEATED FOR THE POSTERIOR RECTAL WALL. ON THE THIRD POSTOPERATIVE DAY, THE SECOND PATIENT IN THE PRESENT SERIES, IN WHOM REINFORCEMENT OF THE SUTURE LINE WAS NOT CARRIED OUT, EXPERIENCED MASSIVE RECTAL BLEEDING REQUIRING TRANSFUSION AND RE-INTERVENTION. EARLY POSTOPERATIVE GENERAL COMPLICATION INCLUDED FEVER OF UNKNOWN ORIGIN (N=1). LESS PAIN WAS REPORTED WITH NO PATIENT EXCEEDED THE 90MG DOSE OF KETOROLAC IN THE FIRST POSTOPERATIVE WEEK. LATE SPECIFIC COMPLICATIONS INCLUDED URGE TO DEFECATE (N=3) AND INCONTINENCE TO FLATUS (N=8). STARR SEEMS TO GIVE SEVERAL BENEFITS: IT IS TECHNICALLY EASIER THAN TRADITIONAL PROCEDURES, OPERATIVE TIME AND HOSPITAL STAY ARE SHORT, POSTOPERATIVE PAIN IS MINIMAL, AND TIME TO RESUMPTION OF NORMAL ACTIVITY IS SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524621 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention